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MIRACLE EF Clinical Study (MIRACLE EF)

Primary Purpose

Congestive Heart Failure, Left Bundle Branch Block, Systolic Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CRT-P Implant
CRT-P OFF
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Patient has diagnosis of chronic heart failure > 90 days in duration
  • Has left ventricular ejection fraction (LVEF) between 36% and 50%, inclusive, as documented at baseline or within 30 days prior to enrollment
  • Is either: (a) NYHA Class III at enrollment or at baseline OR (b) NYHA Class II at enrollment or at baseline, with a documented hospitalization for HF in the 12 months prior to enrollment OR (c) NYHA Class II at enrollment or at baseline, without a documented hospitalization for HF in the prior 12 months, but with BNP ≥250 pg/ml or NT-proBNP ≥1000 pg/ml
  • Has documented left bundle branch block (LBBB) with QRS ≥130ms at baseline or within 30 days prior to enrollment.
  • Is in sinus rhythm at time of enrollment or at the baseline visit.
  • Has had no additions to or subtractions from non-diuretic heart failure medical therapy within 30 days prior to enrollment
  • Is on maximum tolerated (guideline) dosages of medications in ACC/AHA guidelines for HF, Ischemic Heart Disease, Hypertension and AF as appropriate.
  • Has signed and dated the study informed consent.
  • Is able to receive a pectoral CRT-P implant.
  • Is expected to remain available for follow-up visits.
  • Is willing and able to comply with the Clinical Investigation Plan.

Exclusion Criteria:

  • Requires permanent cardiac pacing.
  • Indicated for implantable cardioverter defibrillator (ICD), such as for secondary prevention of prior sudden cardiac arrest, related to prior history of ventricular tachycardia and/or ventricular fibrillation.
  • Less than 18 years of age, or under a higher minimum age requirement as defined by local law.
  • Unstable angina or an acute MI within 40 days prior to enrollment.
  • Coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within the 90 days prior to enrollment.
  • Chronic (permanent) atrial arrhythmias. Chronic (permanent) atrial arrhythmias are defined as cases of long-standing atrial fibrillation (e.g., greater than 1 year) in which cardioversion has not been indicated or attempted.
  • Cardioversion for atrial fibrillation within 30 days prior to enrollment.
  • Treatable pericardial constraint within 30 days prior to enrollment.
  • Restrictive (infiltrative) cardiomyopathies, such as amyloidosis, sarcoidosis, or hemochromatosis.
  • Enrolled in a concurrent study, with the exception of a study-manager approved study that is strictly observational in nature and does not confound the results of this study (e.g. registries).
  • Life expectancy of less than 24 months due to non-cardiac conditions.
  • Pregnant, or of childbearing potential and not on a reliable form of birth control.
  • CRT-P, pacemaker, ICD or CRT-D device implanted previously, or currently.
  • Restrictive, hypertrophic, or reversible cardiomyopathy.
  • Mechanical right heart valve.
  • Primary valvular disease and is indicated for valve repair or replacement.
  • Heart transplant, or is currently on a heart transplant list.
  • Significant renal dysfunction, as manifested by serum creatinine level >2.5 mg/dl or ≥275 μmol/L or estimated glomerular filtration rate (GFR) ≤30 mL/min/1.73 m2, which is documented within the 30 days prior to enrollment or at baseline.
  • Significant hepatic dysfunction, as evidenced by a hepatic function panel (serum) > 3 times upper limit of normal, which is documented within the 30 days prior to enrollment or at baseline.
  • Chronic or treatment-resistant severe anemia (hemoglobin <10.0 g/dL), which is documented within the 30 days prior to enrollment or at baseline.
  • On intravenous inotropic drug therapy.

Sites / Locations

  • John Muir Medical Center, Cor Cardiovascular Specialists, John Muir Medical Center (Concord), John Muir Cardiovascular Institute, Contra Costa Cardiology
  • Scripps Clinic Torrey Pines, Scripps Green Hospital
  • VA Greater Los Angeles Healthcare System
  • Eisenhower Desert Cardiology Center, Eisenhower Medical Center Hospital
  • Los Robles Medical Center
  • Colorado Health Medical Group, Memorial Hospital Colorado Springs
  • Hartford Hospital
  • Bradenton Cardiology, Manatee Memorial Hospital
  • Melbourne Internal Medicine Associates / Century Research Associates, Holmes Regional Medical Center Hospital
  • Aventura Hospital and Medical Center, Hospital Corporation of America (Aventura), Hospital Corporation of America (Miami)
  • Emory University Hospital Midtown
  • WellStar Cobb Hospital, WellStar Kennestone Hospital
  • Advocate Medical Group, Midwest Heart Specialists (Elmhurst), Elmhurst Memorial Hospital
  • Advocate Christ Medical Center
  • Prairie Education and Research Cooperative (Springfield IL), Prairie Education Research Consultants, St. John's Hospital (Springfield IL)
  • McFarland Clinic PC
  • Cardiovascular Medicine PC (Davenport IA), Trinity (Rock Island), Midwest Cardiovascular Research Foundation, Trinity Bettendorf Hospital
  • Midwest Cardiology Associates PA, Menorah Medical Center, Centerpoint Medical Center, Overland Park Regional Medical Center Hospital
  • Lahey Hospital & Medical Center
  • Sparrow Clinical Research Institute, McLaren Hospital
  • William Beaumont Hospital
  • HealthEast HeartCare Clinic at Saint John's
  • Minneapolis Heart Institute Foundation
  • The Cardiovascular Center, University of Minnesota Medical Center Fairview
  • North Memorial Heart and Vascular Institute, North Memorial Medical Center
  • CentraCare Heart & Vascular Center
  • Minneapolis Heart Institute Foundation, Mercy Hospital (Coon Rapids MN), Unity Hospital, United Hospital, Abbott Northwestern Hospital
  • Missouri Cardiovascular Specialists, Boone Hospital Center
  • Cardiovascular Consultants, P.C., Saint Luke's Hospital, Mid America Heart Institute (MAHI)
  • Mercy Heart and Vascular Clinic, Mercy Hospital St. Louis
  • Glacier View Research Institute Cardiology, Duplicate Glacier View Research Institute Hospital
  • Hackensack University Medical Center
  • New Mexico Heart Institute PA
  • Buffalo Heart Group LLP, Buffalo Heart Group LLC-Cheektowaga, Mercy Hospital of Buffalo
  • Stony Brook Islandia Clinic, Stony Brook Hauppauge, Stony Brook University Medical Center
  • Duke University Medical Center (DUMC)
  • Durham VA Medical Center, Duke University Medical Center
  • FirstHealth Cardiology Services, FirstHealth Moore Regional Hospital
  • Forsyth Medical Center, Novant Clinical Research Institute
  • Sanford Medical Center
  • Lindner Research Center, The Christ Hospital
  • Ohio State University, Ohio State University Medical Center The Richard M Ross Heart Hospital
  • Mercy Hospital Fairfield, Mercy Hospital Anderson, The Jewish Hospital
  • Integris Baptist Medical Center
  • Samaritan Health Services
  • Oregon Health & Science University
  • Lehigh Valley Hospital
  • Mercer Bucks Cardiology, Saint Mary Medical Center, Arrhythmia Institute Hospital
  • University of Pittsburgh Medical Center UPMC Presbyterian
  • Cardiac Diagnostic Associates, York Hospital
  • Pee Dee Cardiology, McLeod Regional Medical Center
  • Arrhythmia Consultants (Greenville SC), Greenville Memorial Hospital
  • Cardiology Consultants PA, Spartanburg Regional Hospital
  • Wellmont CVA Heart Institute, Wellmont Holston Valley Medical Center
  • Centennial Heart Cardiovascular Consultants LLC
  • Saint Thomas Research Institute LLC, Baptist Hospital
  • Amarillo Heart Group, Northwest Texas Hospital
  • Cardiology Center of Amarillo, Northwest Texas Hospital
  • HeartPlace Cardiology Research, Baylor Heart & Vascular Hospital
  • Methodist DeBakey Cardiology Associates, The Methodist Hospital
  • Baylor Research Institute (Plano TX), Legacy Heart Center
  • Scott & White Hospital
  • Fletcher Allen Medical Center
  • University of Virginia (UVA) Medical Center
  • Centra Medical Group Stroobants Cardiovascular Center, Centra Lynchburg General Hospital
  • Richmond Cardiology Associates, Bon Secours Memorial Regional Medical Center
  • Sentara Cardiovascular Specialist, Sentara Williamsburg Regional Medical Center, Sentara Norfolk General Hospital, Sentara Virginia Beach General Hospital
  • Harborview Medical Center, University of Washington (UW) Medical Center
  • Aurora Cardiovascular Services, Aurora Sinai Medical Center, Aurora Saint Luke's Medical Center
  • Medanta-The Medicity
  • Tyumen Cardiology Center
  • Karolinska University Hospital
  • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CRT-P ON

CRT-P OFF

Arm Description

CRT-P Implant CRT-P ON

CRT-P Implant CRT-P OFF

Outcomes

Primary Outcome Measures

Mortality or Heart Failure Morbidity
Primary Efficacy Endpoint: The time to first event, with event defined as: All-cause mortality, or HF Event, defined as either: Inpatient hospitalization for HF, or Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay Note: No endpoints were reached, so this objective was not analyzed
System-related Complication
Primary Safety Endpoint: Time to first system-related complication in subjects with a successful implant. Note: Because of the small number of subjects, number of complications was noted between arms and a time to event analysis was not performed. Complication is defined as: An adverse event that results in death, involves any termination of significant device function, or requires an invasive intervention

Secondary Outcome Measures

Mortality
Time to death between the study groups Note: No endpoints were reached, so this objective was not analyzed
Mortality or Heart Failure Morbidity or Worsening Systolic Function
Secondary Composite Efficacy Endpoint: The time to first event, with event defined as: All-cause mortality HF Event, defined as either: Inpatient hospitalization for HF, or Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay, or Worsening systolic function meeting an ICD/CRT-D indication, defined as: A drop in LVEF to 35% or below, with an absolute decrease of greater than or equal to 10%, after maximum tolerated doses of guideline HF medications have been established Note: No endpoints were reached, so this objective was not analyzed
Recurrent HF Events
The frequency of HF events between the study groups Note: No endpoints were reached, so this objective was not analyzed - HF Event, defined as either: Inpatient hospitalization for HF, or Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay
Quality of Life (QoL)
The quality of life between study groups and the change in quality of life over time between study groups using clinically accepted quality of life measures. Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed. Two QOL questionnaires were used in the study. EQ-5D: scores typically range from 0-1, where higher scores reflect better quality of life KCCQ: scores range from 0-100, where higher scores reflect better quality of life
Reverse Remodeling by Echocardiography
The change in LVEF between study groups. Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed.

Full Information

First Posted
November 15, 2012
Last Updated
October 5, 2017
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01735916
Brief Title
MIRACLE EF Clinical Study
Acronym
MIRACLE EF
Official Title
MIRACLE EF Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early due to low enrollment.
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is looking at whether the electrical treatment provided by a special type of pacemaker called a Cardiac Resynchronization Therapy (CRT) pacemaker may keep a patient's heart failure from getting worse. When the lower heart chambers (i.e. ventricles) are electrically paced to beat together by the CRT pacemaker, blood may be pumped to the body more efficiently. The CRT pacemaker being studied in this clinical trial is approved by the US Food and Drug Administration (FDA) for patients with moderate to severe heart failure, whose hearts pump blood inefficiently. In the MIRACLE EF study, patients who have heart failure with slightly less inefficient hearts will be observed to see if the electrical pacing treatment is better than not getting the treatment. This study is being conducted to support FDA approval of this type of pacemaker for people whose heart failure is less inefficient.
Detailed Description
Medtronic, Inc. is sponsoring the MIRACLE EF study, a prospective, randomized, controlled, double-blinded, global multi-center, Cardiac Resynchronization Therapy (CRT) in Heart Failure (HF) clinical study. The purpose of this study is to evaluate market released CRT pacemaker (CRT-P) devices in symptomatic HF patients with less severe left ventricular systolic dysfunction, specifically patients with reduced left ventricular ejection fraction (LVEF) in the range of 36% to 50%. This study will support expansion of indications for CRT worldwide. The outcome of this study is expected to support modification of existing U.S. and Japanese labeling for Medtronic's implantable CRT-P devices and to provide further evidence to support changes to cardiology practice guidelines (ACC/AHA, ESC guidelines) regarding the use of CRT in patients with mild to moderate HF. Following enrollment and the baseline assessment, eligible subjects will be implanted with a CRT-P system and randomized in a 2:1 fashion to either treatment (CRT-P ON) or control (CRT-P OFF) groups. Study subjects will be followed for a minimum of 24 months or until study closure, and will remain in their randomized groups until their 60 month visit or until the study is stopped, whichever comes first. The effectiveness of CRT-P in this population will be assessed using a composite endpoint of time to first event, with event defined as All-cause mortality or HF Event. To assess the safety of CRT-P in this population, the primary safety endpoint will measure freedom from system-related complications at 6 months post-implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Left Bundle Branch Block, Systolic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT-P ON
Arm Type
Active Comparator
Arm Description
CRT-P Implant CRT-P ON
Arm Title
CRT-P OFF
Arm Type
Placebo Comparator
Arm Description
CRT-P Implant CRT-P OFF
Intervention Type
Device
Intervention Name(s)
CRT-P Implant
Other Intervention Name(s)
Cardiac Resynchronization Therapy Pacemaker (CRT-P), Consulta CRT-P, C4TR01
Intervention Description
The Medtronic Consulta CRT-P (models C3TR01, C4TR011) dual chamber implantable pacemaker with cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, and sequential biventricular pacing. The device senses the electrical activity of the patient's heart using the electrodes of the implanted atrial and right ventricular leads. It then analyzes the heart rhythm based on selectable detection parameters. The device responds to bradyarrhythmias by providing bradycardia pacing therapy. Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
Intervention Type
Device
Intervention Name(s)
CRT-P OFF
Intervention Description
Device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Primary Outcome Measure Information:
Title
Mortality or Heart Failure Morbidity
Description
Primary Efficacy Endpoint: The time to first event, with event defined as: All-cause mortality, or HF Event, defined as either: Inpatient hospitalization for HF, or Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay Note: No endpoints were reached, so this objective was not analyzed
Time Frame
From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months
Title
System-related Complication
Description
Primary Safety Endpoint: Time to first system-related complication in subjects with a successful implant. Note: Because of the small number of subjects, number of complications was noted between arms and a time to event analysis was not performed. Complication is defined as: An adverse event that results in death, involves any termination of significant device function, or requires an invasive intervention
Time Frame
From the date of implant to the date of 6 month follow-up visit
Secondary Outcome Measure Information:
Title
Mortality
Description
Time to death between the study groups Note: No endpoints were reached, so this objective was not analyzed
Time Frame
From date of randomization to date of death, for a minimum of 24 months and up to 60 months
Title
Mortality or Heart Failure Morbidity or Worsening Systolic Function
Description
Secondary Composite Efficacy Endpoint: The time to first event, with event defined as: All-cause mortality HF Event, defined as either: Inpatient hospitalization for HF, or Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay, or Worsening systolic function meeting an ICD/CRT-D indication, defined as: A drop in LVEF to 35% or below, with an absolute decrease of greater than or equal to 10%, after maximum tolerated doses of guideline HF medications have been established Note: No endpoints were reached, so this objective was not analyzed
Time Frame
From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months
Title
Recurrent HF Events
Description
The frequency of HF events between the study groups Note: No endpoints were reached, so this objective was not analyzed - HF Event, defined as either: Inpatient hospitalization for HF, or Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay
Time Frame
From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months
Title
Quality of Life (QoL)
Description
The quality of life between study groups and the change in quality of life over time between study groups using clinically accepted quality of life measures. Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed. Two QOL questionnaires were used in the study. EQ-5D: scores typically range from 0-1, where higher scores reflect better quality of life KCCQ: scores range from 0-100, where higher scores reflect better quality of life
Time Frame
Assessed from baseline visit to 24-month follow-up visit
Title
Reverse Remodeling by Echocardiography
Description
The change in LVEF between study groups. Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed.
Time Frame
Assessed from baseline visit to 24-month follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has diagnosis of chronic heart failure > 90 days in duration Has left ventricular ejection fraction (LVEF) between 36% and 50%, inclusive, as documented at baseline or within 30 days prior to enrollment Is either: (a) NYHA Class III at enrollment or at baseline OR (b) NYHA Class II at enrollment or at baseline, with a documented hospitalization for HF in the 12 months prior to enrollment OR (c) NYHA Class II at enrollment or at baseline, without a documented hospitalization for HF in the prior 12 months, but with BNP ≥250 pg/ml or NT-proBNP ≥1000 pg/ml Has documented left bundle branch block (LBBB) with QRS ≥130ms at baseline or within 30 days prior to enrollment. Is in sinus rhythm at time of enrollment or at the baseline visit. Has had no additions to or subtractions from non-diuretic heart failure medical therapy within 30 days prior to enrollment Is on maximum tolerated (guideline) dosages of medications in ACC/AHA guidelines for HF, Ischemic Heart Disease, Hypertension and AF as appropriate. Has signed and dated the study informed consent. Is able to receive a pectoral CRT-P implant. Is expected to remain available for follow-up visits. Is willing and able to comply with the Clinical Investigation Plan. Exclusion Criteria: Requires permanent cardiac pacing. Indicated for implantable cardioverter defibrillator (ICD), such as for secondary prevention of prior sudden cardiac arrest, related to prior history of ventricular tachycardia and/or ventricular fibrillation. Less than 18 years of age, or under a higher minimum age requirement as defined by local law. Unstable angina or an acute MI within 40 days prior to enrollment. Coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within the 90 days prior to enrollment. Chronic (permanent) atrial arrhythmias. Chronic (permanent) atrial arrhythmias are defined as cases of long-standing atrial fibrillation (e.g., greater than 1 year) in which cardioversion has not been indicated or attempted. Cardioversion for atrial fibrillation within 30 days prior to enrollment. Treatable pericardial constraint within 30 days prior to enrollment. Restrictive (infiltrative) cardiomyopathies, such as amyloidosis, sarcoidosis, or hemochromatosis. Enrolled in a concurrent study, with the exception of a study-manager approved study that is strictly observational in nature and does not confound the results of this study (e.g. registries). Life expectancy of less than 24 months due to non-cardiac conditions. Pregnant, or of childbearing potential and not on a reliable form of birth control. CRT-P, pacemaker, ICD or CRT-D device implanted previously, or currently. Restrictive, hypertrophic, or reversible cardiomyopathy. Mechanical right heart valve. Primary valvular disease and is indicated for valve repair or replacement. Heart transplant, or is currently on a heart transplant list. Significant renal dysfunction, as manifested by serum creatinine level >2.5 mg/dl or ≥275 μmol/L or estimated glomerular filtration rate (GFR) ≤30 mL/min/1.73 m2, which is documented within the 30 days prior to enrollment or at baseline. Significant hepatic dysfunction, as evidenced by a hepatic function panel (serum) > 3 times upper limit of normal, which is documented within the 30 days prior to enrollment or at baseline. Chronic or treatment-resistant severe anemia (hemoglobin <10.0 g/dL), which is documented within the 30 days prior to enrollment or at baseline. On intravenous inotropic drug therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Linde, MD PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
John Muir Medical Center, Cor Cardiovascular Specialists, John Muir Medical Center (Concord), John Muir Cardiovascular Institute, Contra Costa Cardiology
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Scripps Clinic Torrey Pines, Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Eisenhower Desert Cardiology Center, Eisenhower Medical Center Hospital
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Los Robles Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Colorado Health Medical Group, Memorial Hospital Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Bradenton Cardiology, Manatee Memorial Hospital
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Melbourne Internal Medicine Associates / Century Research Associates, Holmes Regional Medical Center Hospital
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Aventura Hospital and Medical Center, Hospital Corporation of America (Aventura), Hospital Corporation of America (Miami)
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
WellStar Cobb Hospital, WellStar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Advocate Medical Group, Midwest Heart Specialists (Elmhurst), Elmhurst Memorial Hospital
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Prairie Education and Research Cooperative (Springfield IL), Prairie Education Research Consultants, St. John's Hospital (Springfield IL)
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
McFarland Clinic PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Cardiovascular Medicine PC (Davenport IA), Trinity (Rock Island), Midwest Cardiovascular Research Foundation, Trinity Bettendorf Hospital
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Midwest Cardiology Associates PA, Menorah Medical Center, Centerpoint Medical Center, Overland Park Regional Medical Center Hospital
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Sparrow Clinical Research Institute, McLaren Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
HealthEast HeartCare Clinic at Saint John's
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
The Cardiovascular Center, University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
North Memorial Heart and Vascular Institute, North Memorial Medical Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
CentraCare Heart & Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Minneapolis Heart Institute Foundation, Mercy Hospital (Coon Rapids MN), Unity Hospital, United Hospital, Abbott Northwestern Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Missouri Cardiovascular Specialists, Boone Hospital Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Cardiovascular Consultants, P.C., Saint Luke's Hospital, Mid America Heart Institute (MAHI)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mercy Heart and Vascular Clinic, Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Glacier View Research Institute Cardiology, Duplicate Glacier View Research Institute Hospital
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New Mexico Heart Institute PA
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Buffalo Heart Group LLP, Buffalo Heart Group LLC-Cheektowaga, Mercy Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Stony Brook Islandia Clinic, Stony Brook Hauppauge, Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University Medical Center (DUMC)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Durham VA Medical Center, Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
FirstHealth Cardiology Services, FirstHealth Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Forsyth Medical Center, Novant Clinical Research Institute
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sanford Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
Lindner Research Center, The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University, Ohio State University Medical Center The Richard M Ross Heart Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Mercy Hospital Fairfield, Mercy Hospital Anderson, The Jewish Hospital
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Samaritan Health Services
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Mercer Bucks Cardiology, Saint Mary Medical Center, Arrhythmia Institute Hospital
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
Facility Name
University of Pittsburgh Medical Center UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Cardiac Diagnostic Associates, York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Pee Dee Cardiology, McLeod Regional Medical Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Facility Name
Arrhythmia Consultants (Greenville SC), Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Cardiology Consultants PA, Spartanburg Regional Hospital
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Wellmont CVA Heart Institute, Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Centennial Heart Cardiovascular Consultants LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Saint Thomas Research Institute LLC, Baptist Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Amarillo Heart Group, Northwest Texas Hospital
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Cardiology Center of Amarillo, Northwest Texas Hospital
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
HeartPlace Cardiology Research, Baylor Heart & Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Methodist DeBakey Cardiology Associates, The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Research Institute (Plano TX), Legacy Heart Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Scott & White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Fletcher Allen Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
University of Virginia (UVA) Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Centra Medical Group Stroobants Cardiovascular Center, Centra Lynchburg General Hospital
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Richmond Cardiology Associates, Bon Secours Memorial Regional Medical Center
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Sentara Cardiovascular Specialist, Sentara Williamsburg Regional Medical Center, Sentara Norfolk General Hospital, Sentara Virginia Beach General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Harborview Medical Center, University of Washington (UW) Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Aurora Cardiovascular Services, Aurora Sinai Medical Center, Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medanta-The Medicity
City
Haryana
ZIP/Postal Code
122041
Country
India
Facility Name
Tyumen Cardiology Center
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

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MIRACLE EF Clinical Study

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