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Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation (CHANGE-AFIB)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dronedarone
Sponsored by
American Heart Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Arrhythmias, Cardiac, Atrial Fibrillation, Anti-Arrhythmic Agents, Heterocyclic Compounds, Dronedarone, Multaq

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age >=21 years
  2. First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 120 days)
  3. Acute care encounter for evaluation or treatment of atrial fibrillation, within 120 days.
  4. Electrocardiographic documentation of atrial fibrillation.
  5. Estimated life expectancy of at least 1 year
  6. Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

  1. Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (>7 days) antiarrhythmic drug therapy.
  2. Prior hospitalization for AF (other than the qualifying event).
  3. Planned cardiothoracic surgery.
  4. New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks.
  5. Patients with reduced ejection fraction (LVEF ≤40%).
  6. Permanent atrial fibrillation.
  7. Ineligible for oral anticoagulation, unless CHA2DS2-VASc is less than 3 in women or 2 in men.
  8. Bradycardia with a resting heart rate < 50 bpm
  9. PR interval >280 msec or 2nd degree or 3rd degree atrioventricular block without a permanent pacemaker/cardiac implanted electronic device.
  10. Corrected QT interval >=500 msec.
  11. Pregnancy or breast feeding.
  12. Severe hepatic impairment in the opinion of the investigator.

Sites / Locations

  • Thomas HospitalRecruiting
  • Mercy Gilbert Medical CenterRecruiting
  • HonorHealth Scottsdale Shea Medical CenterRecruiting
  • Los Angeles Medical Center (Kaiser Permenente)Recruiting
  • West Los Angeles Medical CenterRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • UC Irvine Medical Center (AKA UCI Health)Recruiting
  • Los Robles Health System - Los Robles Regional Medical CenterRecruiting
  • UCLA Medical Center - HarborRecruiting
  • Colorado Heart & Vascular Group - St. Anthony's HospitalRecruiting
  • Colorado Heart & Vascular Group - St. Anthony's North Health CampusRecruiting
  • Christiana HospitalRecruiting
  • First Coast Cardiovascular InstituteRecruiting
  • Ocean Wellness Center, LLCRecruiting
  • Pharma Medical InnovationsRecruiting
  • The Angel Medical ResearchRecruiting
  • Enmanuel Advanced Research Center, LLCRecruiting
  • Life Spring Research Foundation, LLCRecruiting
  • Nouvelle Clinical Research LLCRecruiting
  • Golden Touch Clinical ResearchRecruiting
  • Excellence Medical And Research, LLCRecruiting
  • The Miami Research GroupRecruiting
  • Northside HospitalRecruiting
  • Guardian Angel Research CenterRecruiting
  • Northeast Georgia Medical CenterRecruiting
  • Georgia Arrhythmia Consultants and Research InstituteRecruiting
  • Wellstar Kennestone HospitalRecruiting
  • Mt Sinai Hospital Medical CenterRecruiting
  • Rush University Medical CenterRecruiting
  • University of Illinois HospitalRecruiting
  • Riverside Medical CenterRecruiting
  • Loyola University Medical CenterRecruiting
  • Captain James A Lovell Federal Health Care CenterRecruiting
  • Proctor Community HospitalRecruiting
  • Methodist Medical Center of IllinoisRecruiting
  • Trinity Rock IslandRecruiting
  • St. Elizabeth's Hospital of the Hospital Sisters of the Third Order of St. FrancisRecruiting
  • St. John's Hospital of the Hospital Sisters of the Third Order of St. FrancisRecruiting
  • Carle Foundation HospitalRecruiting
  • Parkview Hospital, Inc.Recruiting
  • Ascension St Vincent Hospital - IndianapolisRecruiting
  • Kansas City Heart and Vascular Specialists at Providence Medical CenterRecruiting
  • Overland Park Regional Medical CenterRecruiting
  • Baptist Health LexingtonRecruiting
  • Saint Joseph HospitalRecruiting
  • Heart Clinic of HammondRecruiting
  • Tulane Medical CenterRecruiting
  • Luminis Health Anne Arundel Medical CenterRecruiting
  • Saint Agnes HospitalRecruiting
  • Adventist Healthcare Shady Grove Medical CenterRecruiting
  • Brigham and Womens HospitalRecruiting
  • McLaren Bay RegionRecruiting
  • DMC Harper University Hospital (AKA Wayne State University Hospital)Recruiting
  • Sparrow HospitalRecruiting
  • McLaren MacombRecruiting
  • Trinity Health Ann Arbor Hospital - Michigan HeartRecruiting
  • Minneapolis VA Health Care SystemRecruiting
  • University Hospital - University of MissouriRecruiting
  • Barnes-Jewish Hospital (AKA Washington Univ)Recruiting
  • SSM Health Saint Louis University HospitalRecruiting
  • Mercy Hospital SpringfieldRecruiting
  • CHI Health Creighton University Medical Center - Bergan MercyRecruiting
  • Cooper University HospitalRecruiting
  • The Valley HospitalRecruiting
  • Albany Medical CenterRecruiting
  • NYC Health and Hospitals - LincolnRecruiting
  • NYC Health and Hospitals - JacobiRecruiting
  • NYC Health and Hospitals - North Central BronxRecruiting
  • NewYork-Presbyterian/Columbia University Irving Medical CenterRecruiting
  • Memorial Sloan KetteringRecruiting
  • DiGiovanna Institute for Medical Education & ResearchRecruiting
  • Duke University HospitalRecruiting
  • Durham VA Health Care SystemRecruiting
  • WakeMed Raleigh CampusRecruiting
  • New Hanover Regional Medical CenterRecruiting
  • Trinity HospitalRecruiting
  • The MetroHealth SystemRecruiting
  • Kettering Health DaytonRecruiting
  • Miami Valley HospitalRecruiting
  • Kettering Medical CenterRecruiting
  • McLaren - St Lukes HospitalRecruiting
  • Wooster Community Hospital Health SystemRecruiting
  • Oklahoma City VA Health Care SystemRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Penn State Health Holy Spirit Medical CenterRecruiting
  • Penn State Health Milton S Hershey Medical CenterRecruiting
  • Penn State Health St Joseph Medical Center - Main CampusRecruiting
  • Ascension Saint Thomas MidtownRecruiting
  • Ascension Seton Medical Center AustinRecruiting
  • Texas Health Fort Worth (FKA Texas Health Harris Methodist Hospital Fort Worth)Recruiting
  • Memorial Hermann - Texas Medical CenterRecruiting
  • Texas Institute of CardiologyRecruiting
  • Synapse Clinical ResearchRecruiting
  • University Hospital at University of Texas San AntonioRecruiting
  • University of Utah HospitalRecruiting
  • Chippenham and Johnston Willis Medical CenterRecruiting
  • Hunter Holmes McGuire VA Medical Center (AKA Richmond VA Medical Center)Recruiting
  • JW Ruby Memorial HospitalRecruiting
  • Mayo Clinic Hospital - Franciscan Healthcare La CrosseRecruiting
  • UW Health at the American Center (AKA UW Health East Madison Hospital)Recruiting
  • University Hospital - University of Wisconsin-MadisonRecruiting
  • Marshfield Medical CenterRecruiting
  • Marshfield Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dronedarone

Usual care

Arm Description

In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. As dronedarone has anti-adrenergic rate controlling properties, a low dose of beta-blocker or calcium-channel blocker is recommended in the United States Prescribing Information (USPI) when starting dronedarone. In the dronedarone arm concomitant digoxin use will be contraindicated due to P-gp interaction based upon data from the PALLAS trial. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.

In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.

Outcomes

Primary Outcome Measures

Cardiovascular Hospitalization or Death
First occurrence of unplanned CV hospitalization or death from any cause within 12 months of randomization. All unplanned hospitalizations (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) for cardiovascular causes will be considered a cardiovascular hospitalization.

Secondary Outcome Measures

Win Ratio
Among the randomized patients, every patient in the dronedarone arm will be compared with every patient in the usual care arm. Within each pair of patients, the component outcomes will be compared in descending order of importance until one of the patients in the pair demonstrates a better outcome compared with the other. For the purpose of this trial the hierarchy of component outcomes are shown below. The components in the WIN ratio hierarchy are similar to the endpoints considered in the recent EAST AFNET4 trial. Hierarchy of Outcomes for the WIN Ratio: All-cause mortality Ischemic stroke or systemic embolism Hospitalization for new/worsening diagnosis of heart failure Hospitalization for acute coronary syndrome
All-cause mortality
For descriptive purposes, deaths will be categorized by the site investigators according to the following categories: cardiovascular and non-cardiovascular. Cardiovascular deaths will be further classified into arrhythmic vs non-arrhythmic according the modified Hinkle-Thaler criteria, as used in several landmark cardiovascular trials. Patients who are well and (1) have a witnessed sudden collapse or (2) those found dead, but known to be alive and well in the previous 24 hours (e.g. no signs or symptoms of cardiorespiratory distress) will be defined as having arrhythmic death.
Ischemic stroke or systemic embolism
The occurrence of ischemic stroke will be defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Symptoms or signs must persist ≥24 hours, unless the stroke is documented by CT, MRI or autopsy, in which case the duration of symptoms/signs may be less than 24 hours. Stroke may be classified as ischemic (including hemorrhagic transformation of ischemic stroke), hemorrhagic, or undetermined. Systemic embolism will be defined as acute arterial insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g., trauma, atherosclerosis, or instrumentation).
Hospitalization for new/worsening diagnosis of heart failure
Hospitalization for new or worsening heart failure will be defined as any unplanned hospitalization (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) due to a new diagnosis or worsening symptomatic heart failure
Hospitalization for acute coronary syndrome
Any hospitalization (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) due to acute coronary syndrome.
Time to first unplanned cardiovascular hospitalization
Given the importance of CV hospitalization as an outcome from a clinical perspective, patient perspective, and economic perspective, there will be two analyses of CV hospitalization. The key secondary endpoint will be time to first unplanned CV hospitalization (similar to the component of the primary endpoint).
Unplanned cardiovascular hospitalizations--secondary analysis using Anderson-Gill extension
Given the importance of CV hospitalization as an outcome from a clinical perspective, patient perspective, and economic perspective, there will be two analyses of CV hospitalization. The second exploratory analysis of unplanned cardiovascular hospitalization will use a method to account for repeated events (Anderson-Gill extension).

Full Information

First Posted
October 27, 2021
Last Updated
October 3, 2023
Sponsor
American Heart Association
Collaborators
Duke Clinical Research Institute, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT05130268
Brief Title
Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation
Acronym
CHANGE-AFIB
Official Title
Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons With First-Detected Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Heart Association
Collaborators
Duke Clinical Research Institute, Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
While there are several completed clinical trials that address treatment strategy in patients with symptomatic and recurrent AF, there are no randomized clinical trials that address treatment for first-detected AF. In usual care, these patients are started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker) along with stroke prevention therapy. The investigators hypothesize that earlier administration of a well-tolerated antiarrhythmic drug proven to reduce hospitalization may result in improved cardiovascular outcomes and quality of life in patients first-detected AF. The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected AF. All patients will be treated with guideline-recommended stroke prevention therapy according to the CHA2DS2-VASc score. The treatment follow-up period will be 12 months. There will be two follow-up visits. Consistent with the pragmatic nature of the trial, the first follow-up will occur between 3 -9 months and the 2nd will occur at 12 months (with a window of +/- 30 days). Approximately 3000 patients will be enrolled and randomly assigned (1:1) to study intervention. The study intervention will be dronedarone 400 mg twice daily in addition to usual care versus usual care alone.
Detailed Description
Atrial fibrillation (AF) is the most common sustained arrhythmia encountered in clinical practice, accounting for one-third of arrhythmia-related hospitalizations.1 As many as 1 in 4 people develop AF over their lifetime after the age of 40 years. The prevalence and burden of AF in the United States is substantial; the age-adjusted incidence and prevalence has increased over the last 3 decades. Moreover, the number of Americans with AF is expected to increase 150% by 2050. The goals of care in the treatment of AF include (1) the management and reduction of risk factors, (2) prevention of tachycardia (rate control), (3) prevention of stroke, and (4) improvement of symptoms. Reduction or elimination of symptoms often requires rhythm control. Historically, randomized clinical trials have not demonstrated a mortality or stroke benefit with a rhythm control versus a rate control strategy. Despite the failure of prior randomized clinical trials to demonstrate the superiority of rhythm control, the recent Early Treatment of Atrial Fibrillation for Stroke Prevention 4 (EAST-AFNET 4) trial demonstrated that early introduction of a comprehensive rhythm-control strategy (within one year of diagnosis) is superior to guideline-based usual care in improving cardiovascular (CV) outcomes at a mean follow-up of 5 years. The EAST-AFNET 4 trial found that early rhythm control reduced the primary outcome of CV death, stroke, hospitalization for heart failure (HF), or acute coronary syndrome (HR 0.79, 96% confidence interval (CI) 0.66-0.94, p = 0.005). EAST-AFNET 4 also demonstrated a reduction in the risk of stroke with early introduction of rhythm control (HR 0.65, 95% CI 0.44-0.98), a finding that was also observed with dronedarone in the ATHENA trial. In addition, maintenance of sinus rhythm has been associated with improved quality of life and increased exercise capacity in some patients. Outside of clinical trials, a quality-of-life study from the Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RECORD-AF) found that rhythm control was associated with better quality of life. There are several antiarrhythmic drugs (AADs) available for rhythm control of AF. Class I antiarrhythmic agents are predominantly limited to younger patients without coronary artery or structural heart disease. Patients with advanced chronic kidney disease, prolonged QT intervals, and/or severe left ventricular hypertrophy should not be treated with sotalol or dofetilide. Even when sotalol or dofetilide can be used, patients are often hesitant to start a medication that requires an inpatient hospitalization for drug loading and laboratory evaluation every 3 months. Amiodarone has been shown to be the most effective AAD for maintaining sinus rhythm in patients with AF; however, based on its side effect profile, amiodarone is only recommended as a first-line agent under specific clinical circumstances. Moreover, despite its efficacy, amiodarone has high rates of discontinuation due to frequent adverse events. In addition to its unfavorable side effects, several studies, including those of patients at risk for sudden cardiac death, have demonstrated an association between amiodarone use and higher mortality, as well as lower functional status. In contrast to amiodarone, dronedarone is a much better tolerated antiarrhythmic medication. In randomized controlled trials, dronedarone has been shown to prevent recurrent AF, improve rate control, and decrease cardiovascular hospitalization in patients with AF. While there are several completed clinical trials that address treatment strategy in patients with symptomatic and recurrent AF, there are no randomized clinical trials that address treatment for first-detected or new-onset AF. After appropriate evaluation for oral anticoagulation, these patients are often started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker). The investigators hypothesize that earlier administration of a well-tolerated antiarrhythmic drug proven to reduce hospitalization may result in improved quality of life and cardiovascular outcomes in patients with first-detected AF. Risk Assessment: Dronedarone is approved by the Food and Drug Administration to reduce the risk of hospitalization for AF in patients with paroxysmal or persistent AF. The efficacy and safety of dronedarone 400 mg twice daily was evaluated in five controlled studies, ATHENA, ANDROMEDA, European Trial in Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the Maintenance of Sinus Rhythm (EURIDIS), ADONIS, and Dronedarone Atrial FibrillatioN study after Electrical Cardioversion (DAFNE), involving more than 6,000 patients with including more than 3200 patients who received dronedarone. As with any therapeutic agent, there are known risks with dronedarone therapy. These risks include hepatic injury, heart failure exacerbation, increased exposure to digoxin, increased plasma concentration of tacrolimus, sirolimus, and other Cytochrome P450, family 3, subfamily A (CYP 3A) substrates, and very rare instances of pulmonary toxicity. The risks of dronedarone are felt to be outweighed by its benefits. The guideline recommendations provided by the European Society of Cardiology and American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) are commensurate with this risk benefit assessment. Benefit Assessment: While there are no completed randomized clinical trials to guide selection or initiation of rhythm control therapies in patients with first-detected AF, there are recent trials that suggest benefit with both dronedarone antiarrhythmic therapy and early-initiation of rhythm control in persons with AF. the recent EAST-AFNET 4 trial demonstrated that early introduction of a comprehensive rhythm-control strategy (within one year of diagnosis) is superior to usual guideline-recommended care in improving cardiovascular (CV) outcomes at 5 years. The median time from new-onset AF to randomization in the EAST-AFNET4 trial was 36 days. The trial found that early rhythm control reduced the primary outcome of CV death, stroke, hospitalization for HF, or acute coronary syndrome (HR 0.79, 95% confidence interval 0.66-0.94, p = 0.005). EAST-AFNET 4 also demonstrated a reduction in the risk of stroke with early introduction of rhythm control (HR 0.65, 95% CI 0.44-0.98), a finding that was also observed with dronedarone in the ATHENA trial. Thus, the investigators hypothesize that early initiation of dronedarone in patients with new-onset AF will lead to a reduction in CV hospitalization or death. Overall Design: Dronedarone is approved by the Food and Drug Administration to reduce the risk of CV hospitalization in patients with AF or atrial flutter. However, it is unknown if dronedarone (or any antiarrhythmic medication) can reduce CV hospitalization or death in patients with first-detected AF. This trial has been designed to address this important question. In order to facilitate the trial enrollment, data collection, and a generalizability to clinical practice, the CHANGE AFIB study has been designed as an open-label pragmatic clinical trial nested within the Get With The Guidelines (GWTG) Atrial Fibrillation registry. At present the overall GWTG program is being implemented in over 2,300 hospitals across the U.S. and is comprised of over 9 million patient records, with an estimated 650,000 new patient records entered per year. The trial will utilize the existing GWTG registry network, data collection architecture, and experience to facilitate both enrollment and conduct of the trial. The comparator arm will be "usual care." Thus, this study will compare usual care plus dronedarone versus usual care alone. In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. As dronedarone has anti-adrenergic rate controlling properties, a low dose of beta-blocker or calcium-channel blocker is recommended in the USPI when starting dronedarone. In the dronedarone arm concomitant digoxin use will be contraindicated due to P-gp interaction based upon data from the PALLAS trial. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations. CHANGE AFIB will leverage several critical advantages as a pragmatic clinical trial. Data collection will be integrated into the Get With The Guidelines AFIB registry. The use of the GWTG-AFIB registry will also enhance subject recruitment and ensure the enrollment of a diverse group of patients. The randomized intervention will be compared with usual care thus further enhancing generalizability. Follow-up visits will be minimized to reduce patient burden. Moreover, follow-up visits will have "windows" to accommodate variation in follow-up intervals at different centers. Justification for Study Drug Intervention and Dose: Dronedarone is a non-iodinated benzofuran similar to amiodarone but is not associated with thyroid or pulmonary toxicity in randomized clinical trials or post-marketing observational studies. Dronedarone has electrophysiological characteristics spanning all 4 Vaughan-Williams anti-arrhythmic classes, with primarily class III effects. Initial trials suggested that dronedarone prolonged the time to recurrence of AF and reduced cardiovascular death and hospitalization. The landmark ATHENA trial evaluated the efficacy and safety of dronedarone in patients with atrial arrhythmias (atrial fibrillation or atrial flutter). This trial did not include patients with a recent history of New York Heart Association (NYHA) class IV heart failure or recent hospitalization for decompensated heart failure (<4 weeks). Approximately, 30% of the ATHENA population had NYHA class I-III heart failure. ATHENA demonstrated that dronedarone 400 mg twice daily (in combination with background therapy) reduced the combined endpoint of CV hospitalization or death from any cause by 24% (p<0.001) compared with placebo. Of course, the ATHENA trial was not conducted in the special population of patients with a new diagnosis of AF. There are no randomized trials or guideline recommendations for antiarrhythmic therapy at the time of first-detected AF. A subgroup analysis from the ATHENA trial suggests that optimal outcomes may be achieved in those patients with shorter duration of AF (time from diagnosis). Similar observations have also been made in patients undergoing other forms of rhythm control, including catheter ablation. In this trial, patients with first-detected AF will be randomized to dronedarone on top of usual care versus usual care alone. Patients randomized to the intervention arm will be prescribed and treated with Dronedarone 400 mg bid. This dose has been chosen as it is the Food and Drug Administration approved dose as well as the dose recommended in current international guidelines. Dronedarone has also been shown to be an effective rate control agent as well. In the ERATO study treatment with dronedarone 400 mg twice daily let to a mean reduction of 24.5 beat/min in patients with permanent AF when compared with placebo. In the EURIDIS/ADONIS studies the mean difference in patients with paroxysmal/persistent AF during AF recurrence was 14 beats/min. Moreover, the dronedarone treated patients experienced improved rate control without any reduction in exercise tolerance as measured by maximal exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Arrhythmias, Cardiac, Atrial Fibrillation, Anti-Arrhythmic Agents, Heterocyclic Compounds, Dronedarone, Multaq

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, prospective, randomized, open-label, pragmatic clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dronedarone
Arm Type
Experimental
Arm Description
In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. As dronedarone has anti-adrenergic rate controlling properties, a low dose of beta-blocker or calcium-channel blocker is recommended in the United States Prescribing Information (USPI) when starting dronedarone. In the dronedarone arm concomitant digoxin use will be contraindicated due to P-gp interaction based upon data from the PALLAS trial. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.
Intervention Type
Drug
Intervention Name(s)
Dronedarone
Other Intervention Name(s)
Multaq
Intervention Description
Dronedarone 400 mg twice daily in addition to usual care
Primary Outcome Measure Information:
Title
Cardiovascular Hospitalization or Death
Description
First occurrence of unplanned CV hospitalization or death from any cause within 12 months of randomization. All unplanned hospitalizations (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) for cardiovascular causes will be considered a cardiovascular hospitalization.
Time Frame
Evaluated through 12 months from randomization
Secondary Outcome Measure Information:
Title
Win Ratio
Description
Among the randomized patients, every patient in the dronedarone arm will be compared with every patient in the usual care arm. Within each pair of patients, the component outcomes will be compared in descending order of importance until one of the patients in the pair demonstrates a better outcome compared with the other. For the purpose of this trial the hierarchy of component outcomes are shown below. The components in the WIN ratio hierarchy are similar to the endpoints considered in the recent EAST AFNET4 trial. Hierarchy of Outcomes for the WIN Ratio: All-cause mortality Ischemic stroke or systemic embolism Hospitalization for new/worsening diagnosis of heart failure Hospitalization for acute coronary syndrome
Time Frame
Evaluated through 12 months from randomization
Title
All-cause mortality
Description
For descriptive purposes, deaths will be categorized by the site investigators according to the following categories: cardiovascular and non-cardiovascular. Cardiovascular deaths will be further classified into arrhythmic vs non-arrhythmic according the modified Hinkle-Thaler criteria, as used in several landmark cardiovascular trials. Patients who are well and (1) have a witnessed sudden collapse or (2) those found dead, but known to be alive and well in the previous 24 hours (e.g. no signs or symptoms of cardiorespiratory distress) will be defined as having arrhythmic death.
Time Frame
Evaluated through 12 months from randomization
Title
Ischemic stroke or systemic embolism
Description
The occurrence of ischemic stroke will be defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Symptoms or signs must persist ≥24 hours, unless the stroke is documented by CT, MRI or autopsy, in which case the duration of symptoms/signs may be less than 24 hours. Stroke may be classified as ischemic (including hemorrhagic transformation of ischemic stroke), hemorrhagic, or undetermined. Systemic embolism will be defined as acute arterial insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g., trauma, atherosclerosis, or instrumentation).
Time Frame
Evaluated through 12 months from randomization
Title
Hospitalization for new/worsening diagnosis of heart failure
Description
Hospitalization for new or worsening heart failure will be defined as any unplanned hospitalization (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) due to a new diagnosis or worsening symptomatic heart failure
Time Frame
Evaluated through 12 months from randomization
Title
Hospitalization for acute coronary syndrome
Description
Any hospitalization (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) due to acute coronary syndrome.
Time Frame
Evaluated through 12 months from randomization
Title
Time to first unplanned cardiovascular hospitalization
Description
Given the importance of CV hospitalization as an outcome from a clinical perspective, patient perspective, and economic perspective, there will be two analyses of CV hospitalization. The key secondary endpoint will be time to first unplanned CV hospitalization (similar to the component of the primary endpoint).
Time Frame
Evaluated through 12 months from randomization
Title
Unplanned cardiovascular hospitalizations--secondary analysis using Anderson-Gill extension
Description
Given the importance of CV hospitalization as an outcome from a clinical perspective, patient perspective, and economic perspective, there will be two analyses of CV hospitalization. The second exploratory analysis of unplanned cardiovascular hospitalization will use a method to account for repeated events (Anderson-Gill extension).
Time Frame
Evaluated through 12 months from randomization
Other Pre-specified Outcome Measures:
Title
Any unplanned arrhythmia-related hospitalization
Description
Arrhythmia-Related Hospitalization will be defined as any unplanned hospitalization (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) due to any tachy or brady-arrhythmia.
Time Frame
Evaluated through 12 months from randomization
Title
Number of participants who experience AF progression
Description
AF Progression will be defined as the transition from (a) paroxysmal to persistent or (b) persistent to permanent AF.
Time Frame
Evaluated through 12 months from randomization
Title
Number of participants who undergo cardioversion (pharmacologic or electrical)
Description
Cardioversion (either pharmacologic or electrical) with or without transesophageal echocardiographic guidance will be a tertiary endpoint.
Time Frame
Evaluated through 12 months from randomization
Title
Number of participants who have ablation of AF (catheter, surgical or hybrid) performed
Description
Ablation of AF including catheter ablation, surgical ablation, or hybrid (endocardial and epicardial ablation) ablation will be a tertiary endpoint.
Time Frame
Evaluated through 12 months from randomization
Title
Days alive and outside of the hospital
Description
Days Alive and Out of the Hospital. Days alive and out of the hospital (DAOH, also referred to as "home time") is an emerging clinical trial endpoint that is both pragmatic and patient centered. It is highly correlated with traditional time-to-event mortality and hospitalization outcomes.
Time Frame
Evaluated through 12 months from randomization
Title
Patient-Reported Quality of Life--AFEQT
Description
The AFEQT is a 21-item, AF-specific health-related QOL questionnaire that assesses the impact of AF on patient-reported quality of life. The AFEQT includes a summary score (calculated from 18 of the questions) and subscale scores in three domains: symptoms, daily activities, and treatment concern. The summary and subscale scores range from 0 (corresponds to complete AF-related disability) to 100 (no AF-related disability). A change of 5 or more points in the AFEQT has been identified as a benchmark for a clinically meaningful difference in an individual patient.
Time Frame
At baseline and 12 months
Title
Patient-Reported Quality of Life--MAFSI
Description
The MAFSI was developed as a modification and update of the AF Symptom Checklist. The trial will use a modified MAFSI questionnaire comprised of a 10-item AF symptom checklist that asks about frequency and severity of each symptom. Frequency of symptoms is recorded as 0 (never), 1 (rarely), 2 (sometimes), 3 (often), or 4 (always). These responses are summed for a total Frequency Score that ranges from 0 (no AF symptoms) to 40 (worst score). MAFSI Severity Scores are recorded as 1 (mild), 2 (moderate), or 3 (extreme). Severity scores are summed and range from 0 (no AF symptoms) to 30 (most severe AF symptoms). A clinically meaningful change in the MAFSI has not previously been established and therefore will be considered to be about ¼ of the pooled baseline standard deviation (SD), or 1.6 points for the Frequency Score and 1.3 points for the Severity Score.
Time Frame
At baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >=21 years. First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 120 days). Electrocardiographic documentation of atrial fibrillation. Estimated life expectancy of at least 1 year. Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: 1. Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (>7 days) antiarrhythmic drug therapy. 3. Planned cardiothoracic surgery. 4. New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks. 5. Patients with reduced ejection fraction (LVEF ≤40%). 6. Permanent atrial fibrillation. 7. Ineligible for oral anticoagulation, unless CHA2DS2-VASc is less than 3 in women or 2 in men. 8. Bradycardia with a resting heart rate < 50 bpm 9. PR interval >280 msec or 2nd degree or 3rd degree atrioventricular block without a permanent pacemaker/cardiac implanted electronic device. 10. Corrected QT interval >=500 msec. 11. Pregnancy or breast feeding. 12. Severe hepatic impairment in the opinion of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Johnson, MPH
Phone
+1 (609) 223-3730
Email
ChangeAFib@heart.org
First Name & Middle Initial & Last Name or Official Title & Degree
Susana Almeida-Peters, BN, RN
Phone
+1 (919) TBD-0000
Email
ChangeAF@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Piccini, MD, MHS
Organizational Affiliation
Duke Clinical Research Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhonda Dickinson
Email
rhonda.dickinson@infirmaryhealth.org
First Name & Middle Initial & Last Name & Degree
Michael S. Pursley, MD FACC
Facility Name
Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Eastman, RN
Email
kate.eastman@dignityhealth.org
First Name & Middle Initial & Last Name & Degree
Rachel M. Bond, MD
Facility Name
HonorHealth Scottsdale Shea Medical Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camren Adams
Email
camadams@honorhealth.com
First Name & Middle Initial & Last Name & Degree
Rahul N. Doshi, MD FACC FHRS
Facility Name
Los Angeles Medical Center (Kaiser Permenente)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalia Salazar
Email
dalia.x.salazar@kp.org
First Name & Middle Initial & Last Name & Degree
Nigel Gupta, MD
Facility Name
West Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalia Salazar
Email
Dalia.X.Salazar@kp.org
First Name & Middle Initial & Last Name & Degree
Nigel Gupta, MD
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goran Stankovic
Phone
310-423-1620
Email
goran.stankovic@cshs.org
First Name & Middle Initial & Last Name & Degree
Christine M Albert, MD
Facility Name
UC Irvine Medical Center (AKA UCI Health)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Bernal
Email
bernale2@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Michael Rochon-Duck, MD
Facility Name
Los Robles Health System - Los Robles Regional Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marya Bengali
Email
marya.bengali@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD, FHRS, FACC, FESC
Facility Name
UCLA Medical Center - Harbor
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajad Hamal, MS, CCRP
Phone
310-974-9336
Email
shamal@lundquist.org
First Name & Middle Initial & Last Name & Degree
Houman Khakpour, MD
Facility Name
Colorado Heart & Vascular Group - St. Anthony's Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David E Bailey, BS
Phone
303-595-2619
Email
dbailey@chvpc.com
First Name & Middle Initial & Last Name & Degree
Ganesh Venkataraman, MD
Facility Name
Colorado Heart & Vascular Group - St. Anthony's North Health Campus
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Bailey, BS
Phone
303-595-2619
Email
dbailey@chvpc.com
First Name & Middle Initial & Last Name & Degree
Ganesh Venkataraman, MD
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annamarie Henry, RN, BSN
Email
annhenry@christianacare.org
First Name & Middle Initial & Last Name & Degree
David Kim, MD
Facility Name
First Coast Cardiovascular Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Bonadie, RN
Email
pbonadie@firstcoastcardio.com
First Name & Middle Initial & Last Name & Degree
Yuhning Linda Hu, MD FACC
Facility Name
Ocean Wellness Center, LLC
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Ruiz
Email
druiz@owcclinic.com
First Name & Middle Initial & Last Name & Degree
Jeremy Bleicher, DO MPH
Facility Name
Pharma Medical Innovations
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasnay Arias, RN
Email
yarias@pharmamedinnovations.com
First Name & Middle Initial & Last Name & Degree
Gilberto Concepcion, MD
Facility Name
The Angel Medical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Achong
Email
achong@theangelresearch.com
First Name & Middle Initial & Last Name & Degree
John Dylewski, MD FACC FHRS
Facility Name
Enmanuel Advanced Research Center, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Cabanas
Email
ccabana@enmaresearch.com
First Name & Middle Initial & Last Name & Degree
Arles Perdomo, MD
Facility Name
Life Spring Research Foundation, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvette Rodriguez
Email
yrodriguez@lifespringresearch.com
First Name & Middle Initial & Last Name & Degree
Hector S. Rodriguez, MD
Facility Name
Nouvelle Clinical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilda Cespedes
Email
ncespedes@nouvelleclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Elie R. Haddad, MD
Facility Name
Golden Touch Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurien Cedeno, RN
Email
ycedeno@gtouchresearch.com
First Name & Middle Initial & Last Name & Degree
Giralt Yanez, MD
Facility Name
Excellence Medical And Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isis Gonzalez
Email
igonzalez@emrclinic.com
First Name & Middle Initial & Last Name & Degree
Jeremy Bleicher, DO MPH
Facility Name
The Miami Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Rafael Gonzalez
Email
rgonzalez@miamiresearchgroup.com
First Name & Middle Initial & Last Name & Degree
Manuel A. Franco, MD
Facility Name
Northside Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Nelson, LPN
Email
Michelle.Nelson@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Robert Sheppard, MD
Facility Name
Guardian Angel Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Morales
Email
data2@garesearch.org
First Name & Middle Initial & Last Name & Degree
Liuber Carballar Alberteries, MD
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Patrick, RN
Email
donna.patrick@nghs.com
First Name & Middle Initial & Last Name & Degree
Joon Ahn, MD
Facility Name
Georgia Arrhythmia Consultants and Research Institute
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Semisola Oludare
Email
soludare@gacri.com
First Name & Middle Initial & Last Name & Degree
Felix O. Sogade, MD FACC FHRS
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Bell, BS
Phone
470-793-4066
Email
deborah.bell@wellstar.org
First Name & Middle Initial & Last Name & Degree
Michael J Riley, MC, FACC
Facility Name
Mt Sinai Hospital Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toma Peic Tukuljac
Email
toma.tukuljac@prismsgrp.com
First Name & Middle Initial & Last Name & Degree
Sandeep Khosla, MD FACC FACP FCCP FSCAI
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamil Rahman
Email
jamil_rahman@rush.edu
First Name & Middle Initial & Last Name & Degree
Timothy R. Larsen, DO FACC FHRS
Facility Name
University of Illinois Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yining Chen
Email
yining@uic.edu
First Name & Middle Initial & Last Name & Degree
David Tofovic, MD
Facility Name
Riverside Medical Center
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Koehn, MSN, RN
Phone
815-931-9763
Email
ckoehn@rhc.net
First Name & Middle Initial & Last Name & Degree
Tiffany Furlan, BSN
Phone
815-933-1671
Email
tfurlan@rhc.net
First Name & Middle Initial & Last Name & Degree
Abhimanyu Beri, MD
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Del Priore, RN
Email
jdelpri@luc.edu
First Name & Middle Initial & Last Name & Degree
Menhel Kinno, MD MPH
Facility Name
Captain James A Lovell Federal Health Care Center
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa L Toleda, MSN, RN
Phone
224-610-1310
Email
Teresa.todela@va.gov
First Name & Middle Initial & Last Name & Degree
Kyle B Hines, BSN, RN
Phone
224-610-1307
Email
Kyle.Hines@va.gov
First Name & Middle Initial & Last Name & Degree
Raul J Gazmuri, MD PhD FCCM
Facility Name
Proctor Community Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savannah Cranford, BS, CCRC
Phone
309-672-3118
Email
savannah.cranford@unitypoint.org
First Name & Middle Initial & Last Name & Degree
Sidney M Woll
Phone
309-672-3153
Email
Sidney.Woll@unitypoint.org
First Name & Middle Initial & Last Name & Degree
Alexander Adler, MD
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savannah J Cranford, BS, CCRC
Phone
309-672-3118
Email
Savannah.Cranford@unitypoint.org
First Name & Middle Initial & Last Name & Degree
Sidney Woll
Phone
(309) 672-3153
Email
sidney.woll@unitypoint.org
First Name & Middle Initial & Last Name & Degree
Alexander Adler, MD
Facility Name
Trinity Rock Island
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaina Wagner, RN
Email
shainaw@cvmedpc.com
First Name & Middle Initial & Last Name & Degree
Mark J. Shen, MD, FHRS
Facility Name
St. Elizabeth's Hospital of the Hospital Sisters of the Third Order of St. Francis
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Bainter, RT(R) CCRC
Phone
217-492-9115
Email
lbainter@prairieresearch.com
First Name & Middle Initial & Last Name & Degree
Mark Shen, MD
Facility Name
St. John's Hospital of the Hospital Sisters of the Third Order of St. Francis
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Bainter, RT(R) CCRC
Phone
217-492-9115
Email
lbainter@prairieresearch.com
First Name & Middle Initial & Last Name & Degree
Mark Shen, MD
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carly Skadden, MPH, CCRP
Phone
217-904-7276
Email
caly.skadden@carle.com
First Name & Middle Initial & Last Name & Degree
Mbu Mongwa, MD
Facility Name
Parkview Hospital, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Pyron, RN
Phone
(260)266-5656
Email
matthew.pyron@parkview.com
First Name & Middle Initial & Last Name & Degree
Roy Robertson, MD, FACC, FSCAI
Facility Name
Ascension St Vincent Hospital - Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allyn Harker, RN
Email
allyn.harker@ascension.org
First Name & Middle Initial & Last Name & Degree
Parin J. Patel, MD FACC FHRS
Facility Name
Kansas City Heart and Vascular Specialists at Providence Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Ostrander, MSN APRN FNP NP-C
Email
Eostrander@primehealthcare.com
First Name & Middle Initial & Last Name & Degree
Prasanth S. Katrapati, MD FACC FSCAI RPVI
Facility Name
Overland Park Regional Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Kosbab, LPN
Email
kimberly.kosbab@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Rajesh Kabra, MD FHRS FACC
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40223
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kait Nolan, RN
Phone
859-260-4484
Email
katie.nolan@bhsi.com
First Name & Middle Initial & Last Name & Degree
Gery Tomassoni, MD, FACC
Facility Name
Saint Joseph Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracie Carl-Nagel, RN, BSN, CCRC
Phone
859-313-4459
Email
tracienagel@sjhlex.org
First Name & Middle Initial & Last Name & Degree
Yousef H Darrat, MD
Facility Name
Heart Clinic of Hammond
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Issa Jordan
Email
ibr-ajl@rocketmail.com
First Name & Middle Initial & Last Name & Degree
Ghiath M. Mikdadi, MD FACC FSCAI
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Bowers, RN
Email
sbowers@tulane.edu
First Name & Middle Initial & Last Name & Degree
Anand Irimpen, MD
Facility Name
Luminis Health Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen W Gray, RN
Phone
443-481-5868
Email
kgray7@luminishealth.org
First Name & Middle Initial & Last Name & Degree
Sean Beinart, MD
Facility Name
Saint Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Taylor Blubaugh, NP
Email
htaylor@scritrials.com
First Name & Middle Initial & Last Name & Degree
Jesse A. Doran, MD FACC
Facility Name
Adventist Healthcare Shady Grove Medical Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meseret Y Deressa, MD, MPH
Phone
240-826-6167
Email
MDeressa1@adventisthealthcare.com
First Name & Middle Initial & Last Name & Degree
Shilpa Rele
Phone
240-826-6167
Email
srele@adventisthealthcare.com
First Name & Middle Initial & Last Name & Degree
Omar Shams, MD
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Pellegrini, RN, MSN/MHSA
Phone
617-732-5241
Email
cpellegrini@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Sunil Kapur, MD
Facility Name
McLaren Bay Region
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiona Graham
Email
kiona.graham@mclaren.org
First Name & Middle Initial & Last Name & Degree
Abraham Salacata, MD
Facility Name
DMC Harper University Hospital (AKA Wayne State University Hospital)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Mazzocco, RN
Email
tmazzocco@wayne.edu
First Name & Middle Initial & Last Name & Degree
James H. Paxton, MD MBA FACEP FAHA
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Casler, RN, BSN
Phone
517-364-5734
Email
andrea.casler@sparrow.org
First Name & Middle Initial & Last Name & Degree
John H Ip, MD
Facility Name
McLaren Macomb
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentyna Onishchuk
First Name & Middle Initial & Last Name & Degree
Victor M Hunyadi, DO
Facility Name
Trinity Health Ann Arbor Hospital - Michigan Heart
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Autumn Howe, RN, BSN
Phone
734-712-8387
Email
ahowe@michiganheart.com
First Name & Middle Initial & Last Name & Degree
Edwin T Zishiri, MD
Facility Name
Minneapolis VA Health Care System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Morgan
Email
Jill.Morgan2@va.gov
First Name & Middle Initial & Last Name & Degree
Venkatakrishna Tholakanahalli, MD FHRS
Facility Name
University Hospital - University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Donigian, RN
Phone
573-673-6162
Email
donigianc@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Sandeep Gautam, MD MPH FHRS
Facility Name
Barnes-Jewish Hospital (AKA Washington Univ)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Mills
Email
jamiem@wustl.edu
First Name & Middle Initial & Last Name & Degree
Douglas M. Char, MD
Facility Name
SSM Health Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Lesko, RN, BSN
Email
mary.lesko@health.slu.edu;
First Name & Middle Initial & Last Name & Degree
Philip L Mar, MD, PharmD
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Schrader, RN
Email
Mark.Schrader@Mercy.Net
First Name & Middle Initial & Last Name & Degree
Sunthosh V. Parvathaneni, MD FHRS FACC
Facility Name
CHI Health Creighton University Medical Center - Bergan Mercy
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lois A Rasmussen, BSN, RN, CCRC
Phone
402-343-8539
Email
lois.rasmussen@CHIhealth.com
First Name & Middle Initial & Last Name & Degree
Attila Roka, MD, PhD
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Vasey, BSN, RN
Phone
+1 (856) 342-2000
Ext
1095558
Email
vasey-stephanie@CooperHealth.edu
First Name & Middle Initial & Last Name & Degree
Andrea M. Russo, MD, FACC, FHRS, FAHA
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naomi Hatulan, BSN
Email
nhatula@valleyhealth.com
First Name & Middle Initial & Last Name & Degree
Dan Musat, MD
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gillogly, RN
Email
gillogm@amc.edu
First Name & Middle Initial & Last Name & Degree
Radmila Lyubarova, MD FACC FASE
Facility Name
NYC Health and Hospitals - Lincoln
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beena DaCosta, RN, CCRC, MSN
Email
DSouzaB2@nychhc.org
First Name & Middle Initial & Last Name & Degree
Kenneth Ong, MD
Facility Name
NYC Health and Hospitals - Jacobi
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cidney Schultz, RN
Email
cidney.schultz@nychhc.org
First Name & Middle Initial & Last Name & Degree
Michael J. Grushko, MD
Facility Name
NYC Health and Hospitals - North Central Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raven Dwyer
Email
dwyerr1@nychhc.org
First Name & Middle Initial & Last Name & Degree
Michael Grushko, MD
Facility Name
NewYork-Presbyterian/Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esteban Ceballos
Email
ec3539@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Elaine Y. Wan, MD FACC FAHA FHRS
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Jorgenson
Email
jorgensj@mskcc.org
First Name & Middle Initial & Last Name & Degree
Ioanna Kosmidou, MD PHD
Facility Name
DiGiovanna Institute for Medical Education & Research
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheeba Abraham
Email
dfccresearch@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael DiGiovanna, DO CPI
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan E Pergola
Phone
919-418-0720
Email
meghan.pergola@duke.edu
First Name & Middle Initial & Last Name & Degree
Sean D Pokorney, MD, MBA
Facility Name
Durham VA Health Care System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julienne W Reynolds, BS, BA
Email
julienne.reynolds@va.gov
First Name & Middle Initial & Last Name & Degree
Kathy Aristy, BSN
Email
kathy.aristy@va.gov
First Name & Middle Initial & Last Name & Degree
Albert Sun, MD
Facility Name
WakeMed Raleigh Campus
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LaMonica Daniel
Phone
919-350-7438
Email
LADANIEL@wakemed.org
First Name & Middle Initial & Last Name & Degree
Kevin Manocha, MD
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenji Groesbeck
Email
Ken.Groesbeck@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Meena Rao, MD MPH FACC
Facility Name
Trinity Hospital
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Quam
Email
natalie.quam@trinityhealth.org
First Name & Middle Initial & Last Name & Degree
Samir Turk, MD
Facility Name
The MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pete Leo, RN
Phone
216-778-2714
Email
pleo@metrohealth.org
First Name & Middle Initial & Last Name & Degree
Ohad Ziv, MD
Facility Name
Kettering Health Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton Gerberick
Email
clayton.gerberick@ketteringhealth.org
First Name & Middle Initial & Last Name & Degree
Sameh N. Khouzam, MD
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Bell, RN
Email
hrbell@premierhealth.com
First Name & Middle Initial & Last Name & Degree
Anurag Singh, MD
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton Gerberick
Email
clayton.gerberick@ketteringhealth.org
First Name & Middle Initial & Last Name & Degree
Franklin Handel, MD, FACC
Facility Name
McLaren - St Lukes Hospital
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Miyauchi
Email
Regina.Miyauchi@McLaren.org
First Name & Middle Initial & Last Name & Degree
Chuck Gbur, MD
Facility Name
Wooster Community Hospital Health System
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Stahl, MSN, RN, APRN
Phone
330-263-8359
Email
estahl@wchosp.org
First Name & Middle Initial & Last Name & Degree
Cyril Ofori, MD, FACC
Facility Name
Oklahoma City VA Health Care System
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Farriester
Email
stephen.farriester@va.gov
First Name & Middle Initial & Last Name & Degree
Udho Thadani, MD (MBBS) MRCP FACC FAHA FCCS
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael H Stout, RN
Email
Michael-H-Stout@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Zain Asad, MD, MS, FACC
Facility Name
Penn State Health Holy Spirit Medical Center
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole F Grassmyer, RN
Email
ngrassmyer@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Safwat A Gassis, MD, FACC, MMM, CPEFHRS,
Facility Name
Penn State Health Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Loffredo, RN
Email
kloffredo@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Gerald Naccarelli, MD
Facility Name
Penn State Health St Joseph Medical Center - Main Campus
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emese Futchko, RN,MSN
Email
efutchko@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Christopher B Rogers, DO FACC FACOI
Facility Name
Ascension Saint Thomas Midtown
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Mosley, RN
Email
leslie.mosley1@ascension.org
First Name & Middle Initial & Last Name & Degree
Robert A Pickett, MD
Facility Name
Ascension Seton Medical Center Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Graykowski, RN
Email
Jessica.Graykowski@ascension.org
First Name & Middle Initial & Last Name & Degree
Sarah Benedict
Email
Sarah.Benedict@ascension.org
First Name & Middle Initial & Last Name & Degree
Thomas K Kurian, MD
Facility Name
Texas Health Fort Worth (FKA Texas Health Harris Methodist Hospital Fort Worth)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Wade
Email
rebeccawade@texashealth.org
First Name & Middle Initial & Last Name & Degree
Nitin K Kulkarni, MD
Facility Name
Memorial Hermann - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahra Sorouraddinabadi
Email
Zahra.Sorouraddin@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Olasimbo Chiadika, MD MPH
Facility Name
Texas Institute of Cardiology
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hina Shafiq
Email
hshafiqresearch@ticardiology.com
First Name & Middle Initial & Last Name & Degree
Faisal Wahid, MD FACC FSCAI
Facility Name
Synapse Clinical Research
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77549
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saba Irfan
Email
saba.irfan@synapseclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Naseer N. Khan, MD
Facility Name
University Hospital at University of Texas San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Italia Herrera
Email
herrerai1@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Hemal M Nayak, MD FACC FHRS
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mija Wall
Phone
801-585-2904
Email
mija.wall@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Benjamin A Steinberg, MD, MHS, FACC, FHRS
Facility Name
Chippenham and Johnston Willis Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariana Dickens
Email
ariana.dickens@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Saumil R Shah, MD
Facility Name
Hunter Holmes McGuire VA Medical Center (AKA Richmond VA Medical Center)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Baumgart
Email
Kristina.Baumgart@va.gov
First Name & Middle Initial & Last Name & Degree
Karoly Kaszala, MD PHD
Facility Name
JW Ruby Memorial Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marvin Hudson
Email
marvin.hudson1@wvumedicine.org
First Name & Middle Initial & Last Name & Degree
David Schwartzman, MD FHRS
Facility Name
Mayo Clinic Hospital - Franciscan Healthcare La Crosse
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janel Tunison, BS, CCRP,CSM
Phone
608-392-6880
Email
tunison.janel@mayo.edu
First Name & Middle Initial & Last Name & Degree
Xiaoke Ken Liu, MD PhD
Facility Name
UW Health at the American Center (AKA UW Health East Madison Hospital)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Wittrock
Email
ewittrock@medicine.wisc.edu
First Name & Middle Initial & Last Name & Degree
Matthew M Kalscheur, MD
Facility Name
University Hospital - University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily J Wittrock, BS, CMA
Phone
608-264-1087
Email
ewittrock@medicine.wisc.edu
First Name & Middle Initial & Last Name & Degree
Besa Jonuzi
Email
bjonuzi@wisc.edu
First Name & Middle Initial & Last Name & Degree
Matthew M Kalscheur, MD
Facility Name
Marshfield Medical Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Johnson, CCRP
Phone
715-389-5473
Ext
95473
Email
johnson.megan.a@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Shereif Rezkalla, MD
Facility Name
Marshfield Medical Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Ottosen
Email
ottosen.rebecca@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Sanjay Kumar, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Results Reference
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Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328.
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Roy D, Talajic M, Nattel S, Wyse DG, Dorian P, Lee KL, Bourassa MG, Arnold JM, Buxton AE, Camm AJ, Connolly SJ, Dubuc M, Ducharme A, Guerra PG, Hohnloser SH, Lambert J, Le Heuzey JY, O'Hara G, Pedersen OD, Rouleau JL, Singh BN, Stevenson LW, Stevenson WG, Thibault B, Waldo AL; Atrial Fibrillation and Congestive Heart Failure Investigators. Rhythm control versus rate control for atrial fibrillation and heart failure. N Engl J Med. 2008 Jun 19;358(25):2667-77. doi: 10.1056/NEJMoa0708789.
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Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation

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