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The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation (REACT-AF)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AFSW Guided DOAC
Continuous DOAC therapy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Anticoagulation, AF-sensing Smart Watch, Ischemic Stroke, Systemic Embolism

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, 22-85 years of age. English speaking participants* Documented history of symptomatic or asymptomatic paroxysmal or persistent AF. The duration of AF must have been > 30 seconds as documented by an external monitor or present on 12-lead ECG. CHA2DS2-VASC score of 1-4 without prior stroke or Transient Ischemic Attack (TIA)** The participant is on a DOAC at the time of screening. Willing and able to comply with the protocol, including: Possession of a smartwatch-compatible smartphone (iPhone that supports the latest shipping iOS) with a cellular service plan Be willing to wear the Apple watch at least 14 hours a day Expected to be within cellular service range at least 80% of the time Willing and able to discontinue DOAC The participant is willing and able to provide informed consent. Exclusion Criteria: Valvular or permanent atrial fibrillation. Current treatment with warfarin and unwilling or unable to take a DOAC. The participant is a woman who is pregnant, nursing, or of child-bearing potential and is not on birth control. The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Any documented single AF episode lasting ≥ 1 hour on screening external cardiac monitor of >=6 days duration. Mechanical prosthetic valve(s) or severe valve disease. Hypertrophic cardiomyopathy. Participant needs Direct Oral Anticoagulation (DOAC) for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)) or needs permanent Oral Anticoagulant (OAC) (i.e., congenital heart defects, prosthetic heart valve). Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis > 75%) based on the investigator's discretion. The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn. The participant has a tremor on their ipsilateral side that the AFSW may be worn. Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse). Known hypersensitivity or contraindication to direct oral anticoagulants. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF. > 5% burden premature atrial or ventricular depolarizations on any given calendar day on pre-enrollment cardiac monitoring. History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment). Stage 4 or 5 chronic kidney disease. Conditions associated with an increased risk of bleeding: Major surgery in the previous month Planned surgery or intervention in the next three months. History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra-articular bleeding Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery) Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days Hemorrhagic disorder or bleeding diathesis Need for anticoagulant treatment for disorders other than AF Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of enrollment Uncontrolled hypertension (Systolic Blood Pressure (SBP) >180 mmHg and/or Diastolic Blood Pressure( DBP) >100 mmHg) Spanish-only speakers may be included in the future at select sites where consent forms are appropriately translated. Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction < 40%

Sites / Locations

  • UC Davis HealthRecruiting
  • Scripps Health
  • Stanford UniversityRecruiting
  • University of ColoradoRecruiting
  • South Denver Cardiology Associates, P.C.Recruiting
  • St. Elizabeth's Medical CenterRecruiting
  • Medical Faculty Associates George Washington UniversityRecruiting
  • BayCare Health SystemsRecruiting
  • University of FloridaRecruiting
  • Emory UniversityRecruiting
  • University of Illinois ChicagoRecruiting
  • Northwestern UniversityRecruiting
  • Rush University Medical CenterRecruiting
  • Midwest Cardiovascular InstituteRecruiting
  • Ascension St. VincentRecruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • Johns Hopkins UniveristyRecruiting
  • Brigham and Women's HospitalRecruiting
  • Boston Medical CenterRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Lahey Hospital & Medical CenterRecruiting
  • Henry Ford HealthRecruiting
  • Corewell Health (Former Spectrum Health)Recruiting
  • William Beaumont HospitalRecruiting
  • Hackensack Meridian HealthRecruiting
  • Rutgers, the State University of New JerseyRecruiting
  • The Valley Hospital, Inc.Recruiting
  • Columbia University Medical CenterRecruiting
  • NewYork Presbyterian - QueensRecruiting
  • Westchester Medical CenterRecruiting
  • White Plains HospitalRecruiting
  • University of North CarolinaRecruiting
  • Wake Forest Baptist HealthRecruiting
  • University of Cincinnati College of MedicineRecruiting
  • Allegheny Singer Research InstituteRecruiting
  • Medical University of South CarolinaRecruiting
  • Texas Cardiac Arrhythmia Research FoundationRecruiting
  • University of Texas Southwestern Medical CenterRecruiting
  • University of VirginiaRecruiting
  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AFSW Guided DOAC

Continuous DOAC therapy

Arm Description

All participants randomized to the experimental arm will be provided with an AFSW that will be linked to the participants Apple watch and the secure REACT-AF app within the Eureka cloud. The AFSW will intermittently and passively assess for rhythm irregularities consistent with AF and notify the wearer and coordinating center if a threshold AF event has occurred.

All participants randomized to the control arm will remain on previously prescribed FDA-approved DOAC regimen as indicated by current practice standards. These participants will continuously take DOAC through the course of the study as prescribed by the participants primary physician unless otherwise contraindicated. Participants in the control arm will also use the REACT-AF mobile app within the Eureka platform via Apple watch for study follow-up activities, but the participants will not receive an AFSW and any personally owned Apple Watch will not be loaded with the customized REACT-AF detection algorithm nor participant notification apps.

Outcomes

Primary Outcome Measures

To assess whether AFSW-guided, time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; (3) All-cause mortality.
The primary objective (efficacy objective) of the REACT-AF trial is to assess whether AFSW-guided, time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; and (3) All-cause mortality. Stroke is 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; and classified as ischemic, hemorrhagic, or cause unknown based on CT or Magnetic Resonance (MR) scanning or autopsy. Systemic embolism is defined as an acute vascular occlusion of the extremities or any organ and must be documented by angiography, surgery, scintigraphy, or autopsy and require hospitalization. All-cause mortality will be defined as the underlying disease or injury that initiates the train of events resulting in death.

Secondary Outcome Measures

To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.
Oral anticoagulation carries a risk of major bleeding, including life-threatening hemorrhage, the intervention is expected to reduce the safety endpoint, major bleeding, by > 35%, and the study is powered for the superiority of the safety endpoint. Major bleeding will be defined as requiring hospitalization and by ≥1 of the following International Society on Thrombosis and Haemostasis (ISTH) criteria: (1) Bleeding associated with a reduction in hemoglobin level of at least 2.0 g/dL; (2) Bleeding leading to transfusion of at least two units of blood or packed cells; or (3) Symptomatic bleeding in a critical area or organ such as intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding, or pericardial bleeding.

Full Information

First Posted
April 19, 2023
Last Updated
October 18, 2023
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05836987
Brief Title
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Acronym
REACT-AF
Official Title
REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
July 31, 2029 (Anticipated)
Study Completion Date
July 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.
Detailed Description
REACT-AF is a prospective, unblinded, randomized (1:1 allocation), multi-center, investigational clinical trial of men and women aged 22-85 with a documented history of symptomatic or asymptomatic paroxysmal or persistent (AF) and a moderate risk of stroke measured by CHA2DS2-VASc score 1-4 (which stands for Congestive heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, age 65 to 74 and sex category (female)). Participants randomized to the experimental arm (on demand DOAC) will take the participants DOAC for 30 consecutive days following a qualifying AF episode (i.e., greater than1 hour) detected by the AFSW. Participants randomized to the standard of care (control) arm will remain on previously prescribed continuous DOAC throughout the study. A total of 5350 participants will be enrolled across up to 100 study sites targeting two-thirds academic and one-third private practices, with academic practices also enrolling from affiliated community sites. The investigators anticipate evaluating 7643 consented individuals with external monitoring to ensure that a low AF burden population will be randomized. Up to 200 participants may be enrolled at any one site, and participation will last up to 60 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Anticoagulation, AF-sensing Smart Watch, Ischemic Stroke, Systemic Embolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants randomized (1:1) to the experimental arm (AFSW-guided DOAC) will only take DOAC for 30 consecutive days following a qualifying AF episode (i.e., greater than 1 hour) detected by the participants AFSW if no further AF is detected. Participants randomized to the standard of care arm will remain on continuous DOAC throughout the study.
Masking
Outcomes Assessor
Masking Description
Adjudication of safety events will be performed by a Clinical Endpoint Committee made up of blinded assessors. The Data Coordinating Center (DCC) blinded statistician(s) will also be blinded.
Allocation
Randomized
Enrollment
5350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AFSW Guided DOAC
Arm Type
Experimental
Arm Description
All participants randomized to the experimental arm will be provided with an AFSW that will be linked to the participants Apple watch and the secure REACT-AF app within the Eureka cloud. The AFSW will intermittently and passively assess for rhythm irregularities consistent with AF and notify the wearer and coordinating center if a threshold AF event has occurred.
Arm Title
Continuous DOAC therapy
Arm Type
Active Comparator
Arm Description
All participants randomized to the control arm will remain on previously prescribed FDA-approved DOAC regimen as indicated by current practice standards. These participants will continuously take DOAC through the course of the study as prescribed by the participants primary physician unless otherwise contraindicated. Participants in the control arm will also use the REACT-AF mobile app within the Eureka platform via Apple watch for study follow-up activities, but the participants will not receive an AFSW and any personally owned Apple Watch will not be loaded with the customized REACT-AF detection algorithm nor participant notification apps.
Intervention Type
Device
Intervention Name(s)
AFSW Guided DOAC
Other Intervention Name(s)
Apple Watch
Intervention Description
The AFSW will intermittently and passively assess for rhythm irregularities consistent with AF and notify the wearer and coordinating center if a threshold AF event has occurred.
Intervention Type
Drug
Intervention Name(s)
Continuous DOAC therapy
Other Intervention Name(s)
Oral Anticoagulation therapy
Intervention Description
DOACs will be prescribed to patients according to the treating healthcare provider(s) according to labeling instructions.
Primary Outcome Measure Information:
Title
To assess whether AFSW-guided, time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; (3) All-cause mortality.
Description
The primary objective (efficacy objective) of the REACT-AF trial is to assess whether AFSW-guided, time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; and (3) All-cause mortality. Stroke is 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; and classified as ischemic, hemorrhagic, or cause unknown based on CT or Magnetic Resonance (MR) scanning or autopsy. Systemic embolism is defined as an acute vascular occlusion of the extremities or any organ and must be documented by angiography, surgery, scintigraphy, or autopsy and require hospitalization. All-cause mortality will be defined as the underlying disease or injury that initiates the train of events resulting in death.
Time Frame
At 60 months
Secondary Outcome Measure Information:
Title
To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.
Description
Oral anticoagulation carries a risk of major bleeding, including life-threatening hemorrhage, the intervention is expected to reduce the safety endpoint, major bleeding, by > 35%, and the study is powered for the superiority of the safety endpoint. Major bleeding will be defined as requiring hospitalization and by ≥1 of the following International Society on Thrombosis and Haemostasis (ISTH) criteria: (1) Bleeding associated with a reduction in hemoglobin level of at least 2.0 g/dL; (2) Bleeding leading to transfusion of at least two units of blood or packed cells; or (3) Symptomatic bleeding in a critical area or organ such as intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding, or pericardial bleeding.
Time Frame
At 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, 22-85 years of age. English speaking participants* Documented history of symptomatic or asymptomatic paroxysmal or persistent AF. The duration of AF must have been > 30 seconds as documented by an external monitor or present on 12-lead ECG. CHA2DS2-VASC score of 1-4 without prior stroke or Transient Ischemic Attack (TIA)** The participant is on a DOAC at the time of screening. Willing and able to comply with the protocol, including: Possession of a smartwatch-compatible smartphone (iPhone that supports the latest shipping iOS) with a cellular service plan Be willing to wear the Apple watch at least 14 hours a day Expected to be within cellular service range at least 80% of the time Willing and able to discontinue DOAC The participant is willing and able to provide informed consent. Exclusion Criteria: Valvular or permanent atrial fibrillation. Current treatment with warfarin and unwilling or unable to take a DOAC. The participant is a woman who is pregnant, nursing, or of child-bearing potential and is not on birth control. The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Any documented single AF episode lasting ≥ 1 hour on screening external cardiac monitor of >=6 days duration. Mechanical prosthetic valve(s) or severe valve disease. Hypertrophic cardiomyopathy. Participant needs Direct Oral Anticoagulation (DOAC) for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)) or needs permanent Oral Anticoagulant (OAC) (i.e., congenital heart defects, prosthetic heart valve). Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis > 75%) based on the investigator's discretion. The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn. The participant has a tremor on their ipsilateral side that the AFSW may be worn. Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse). Known hypersensitivity or contraindication to direct oral anticoagulants. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF. > 5% burden premature atrial or ventricular depolarizations on any given calendar day on pre-enrollment cardiac monitoring. History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment). Stage 4 or 5 chronic kidney disease. Conditions associated with an increased risk of bleeding: Major surgery in the previous month Planned surgery or intervention in the next three months. History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra-articular bleeding Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery) Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days Hemorrhagic disorder or bleeding diathesis Need for anticoagulant treatment for disorders other than AF Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of enrollment Uncontrolled hypertension (Systolic Blood Pressure (SBP) >180 mmHg and/or Diastolic Blood Pressure( DBP) >100 mmHg) Spanish-only speakers may be included in the future at select sites where consent forms are appropriately translated. Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction < 40%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Odenwald
Phone
650-725-3187
Email
nicoleod@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rod Passman
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Hanley
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryfel Llanillo
Email
mlparaiso@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Uma Srivatsa
Facility Name
Scripps Health
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Robertson
Email
Robertson.Carolina@scrippshealth.org
First Name & Middle Initial & Last Name & Degree
Janet Lawrence
Email
Lawrence.Janet@scrippshealth.org
First Name & Middle Initial & Last Name & Degree
Evan Muse
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Hernandez
Phone
650-498-7032
Email
alyssahernandez@stanford.edu
First Name & Middle Initial & Last Name & Degree
Alexander Perino
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Collett
Phone
970-624-1581
Email
megan.collett@uchealth.org
First Name & Middle Initial & Last Name & Degree
Tiffany Herrera
Email
tiffany.herrera@uchealth.org
First Name & Middle Initial & Last Name & Degree
Amar Trivedi
Facility Name
South Denver Cardiology Associates, P.C.
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Soltau
Phone
303-703-2191
Email
msoltau@southdenver.com
First Name & Middle Initial & Last Name & Degree
Srikanth Sundaram
Facility Name
St. Elizabeth's Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rina Vaquerano
Phone
617-789-2023
Email
rina.vaquerano@steward.org
First Name & Middle Initial & Last Name & Degree
John Wylie
Facility Name
Medical Faculty Associates George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfateh Sidahmed
Phone
202-741-2353
Email
asidahmed@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Catherine Cantlay
Phone
(202) 741-2559
Email
ccantlay@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Allen Solomon
Facility Name
BayCare Health Systems
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Herring
Phone
813-875-9000
Ext
280209
Email
karen.herring@baycare.org
First Name & Middle Initial & Last Name & Degree
Kevin Makati
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Long
Email
Sarah.Long@medicine.ufl.edu
First Name & Middle Initial & Last Name & Degree
Janette Bostick
Phone
(352) 273-8933
Email
Janette.Bostick@medicine.ufl.edu
First Name & Middle Initial & Last Name & Degree
Mohammed Ruzieh, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30332
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Preiser
Email
tpreise@emory.edu
First Name & Middle Initial & Last Name & Degree
Jovita Brevard
Phone
jovita.johnson@emory.edu
First Name & Middle Initial & Last Name & Degree
Michael Lloyd
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muriel Chen
Email
yining@uic.edu
First Name & Middle Initial & Last Name & Degree
Jood Dabbas
Phone
(312) 355-0700
Email
jdabbas@uic.edu
First Name & Middle Initial & Last Name & Degree
Dana Johnson
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BCVI Clinical Trials Unit
Email
heartresearch@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Bradley Knight
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
Nusrat Jahan
Phone
312-942-1630
Email
nusrat_jahan@rush.edu
First Name & Middle Initial & Last Name & Degree
Mary Ann Donahue
Phone
(312) 942-1309
Email
mary_a_donahue@rush.edu
First Name & Middle Initial & Last Name & Degree
Annabelle Volgman, MD
Facility Name
Midwest Cardiovascular Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josilyn Klimek
Email
Josilyn.Klimek@cardio.com
First Name & Middle Initial & Last Name & Degree
Moeen Saleem
Facility Name
Ascension St. Vincent
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
Regina Margiotti
Phone
317-583-6151
Email
regina.margiotti@ascension.org
First Name & Middle Initial & Last Name & Degree
Ann Renick
Phone
(317) 338-6152
Email
anne.renick@ascension.org
First Name & Middle Initial & Last Name & Degree
Eric Prystowsky
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trisha Elliott
Phone
319-384-1628
Email
trisha-elliott@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Samuel Johnston
Facility Name
Johns Hopkins Univeristy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Martucci
Phone
410-502-0517
Email
mmill148@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Natalie Horstman
Email
nhorstm3@jhu.edu
First Name & Middle Initial & Last Name & Degree
Hugh Calkins
Facility Name
Brigham and Women's 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
Carlos Matostirado
Email
cmatostirado@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Carlos Patino Rivas
Email
cpatinorivas@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Paul Zei, MD
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Gavrilles
Phone
617-638-8718
Email
laura.gavrilles@bmc.org
First Name & Middle Initial & Last Name & Degree
Robert Helm
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenifer M Kaufman
Phone
617-632-8956
Email
jmkaufma@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Patricia Tyler
Phone
(617) 632-7727
Email
ptyler@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Peter Zimetbaum, MD
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Byrne
Phone
781-744-1901
Email
jean.byrne@lahey.org
First Name & Middle Initial & Last Name & Degree
Matthew Reynolds
Facility Name
Henry Ford Health
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Briita Wanhala
Phone
313-916-9575
Email
bwanhal1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Danielle Delmotte
Phone
(313) 916-9575
Email
ddelmot2@hfhs.org
First Name & Middle Initial & Last Name & Degree
Marc Lahiri
Facility Name
Corewell Health (Former Spectrum Health)
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Van Loo
Phone
616-391-3327
Email
lisa.vanloo@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Meaghan Redmond
Phone
(616) 391-2205
Email
meaghan.redmond@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Andre Gauri
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Teefey
Phone
248-898-5584
Email
Jon.teefey@beaumont.org
First Name & Middle Initial & Last Name & Degree
Lauren Scribner
Phone
(248) 898-5590
Email
Lauren.scribner@beaumont.org
First Name & Middle Initial & Last Name & Degree
Nishaki Mehta
Facility Name
Hackensack Meridian Health
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Arakelian
Phone
551-996-5722
Email
Patricia.Arakelian@hmhn.org
First Name & Middle Initial & Last Name & Degree
Tanya Glotzer
Facility Name
Rutgers, the State University of New Jersey
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glaucia Dos Santos-Vaccaro
Phone
732-235-6117
Email
gd301@rwjms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Nivedita Rajiv
Phone
(732) 418-8178
Email
nr505@rwjms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Partho Sengupta
Facility Name
The Valley Hospital, Inc.
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
Kathleen Sayles
Phone
201-447-8453
Email
ksayles@valleyhealth.com
First Name & Middle Initial & Last Name & Degree
Suneet Mittal
Facility Name
Columbia University 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
Phone
917-797-5338
Email
ec3539@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Angelo Biviano
Facility Name
NewYork Presbyterian - Queens
City
Queens
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Lwin
Phone
718-607-2944
Email
bol9009@nyp.org
First Name & Middle Initial & Last Name & Degree
Joon Hyuk Kim
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fnu Namrata
Phone
914-493-5599
Email
fnu.namrata@wmchealth.org
First Name & Middle Initial & Last Name & Degree
Erida Castro-Rivas
Email
Erida.Castro@wmchealth.org
First Name & Middle Initial & Last Name & Degree
Jason Jacobson
Facility Name
White Plains Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aileen Ferrick
Phone
914-849-2690
Email
aferrick@wphospital.org
First Name & Middle Initial & Last Name & Degree
Uloma Ijomah
Phone
(914) 849-2690
Email
uijomah@wphospital.org
First Name & Middle Initial & Last Name & Degree
James Peacock
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Allen
Email
meghme@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Anil Gehi, MD
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keishia Rodriguez
Email
kyrodrig@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Prashant Bhave
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Mardis
Phone
513-558-3711
Email
rachael.mardis@uc.edu
First Name & Middle Initial & Last Name & Degree
Carol Knochelmann
Email
carol.knochelmann@uc.edu
First Name & Middle Initial & Last Name & Degree
Richard Becker
Facility Name
Allegheny Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Phalunas
Phone
412-359-3747
Email
caitlin.phalunas@ahn.org
First Name & Middle Initial & Last Name & Degree
Minesh Lathia
Email
minesh.lathia@ahn.org
First Name & Middle Initial & Last Name & Degree
Amit Thosani
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Winterfield
Phone
843-876-4760
Email
winterfj@musc.edu
First Name & Middle Initial & Last Name & Degree
Rachel Kaplan
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deb Cardinal
Phone
512-431-4868
Email
dscardinal@austinheartbeat.com
First Name & Middle Initial & Last Name & Degree
Amin Al Ahmad
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vukile Mlambo
Phone
214-648-3112
Email
vukile.mlambo@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Mark Link, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Spencer Dennis
Phone
434-982-1058
Email
gvj4ky@virginia.edu
First Name & Middle Initial & Last Name & Degree
Rohit Malhotra
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esoterica Berry
Phone
804-828-4700
Email
esoterica.berry@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Mait Innes
Phone
(804) 628-7455
Email
david.innes@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Kenneth Ellenbogen

12. IPD Sharing Statement

Learn more about this trial

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

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