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DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation (DETERMINE)

Primary Purpose

Coronary Artery Disease, Left Ventricular Dysfunction, Sudden Cardiac Death

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Defibrillator
Control
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary, Artery, Disease, Sudden, Cardiac, Death, ICD

Eligibility Criteria

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

Inclusion Criteria:

Randomized Arm

  1. Evidence of Coronary Artery Disease (CAD)a.
  2. Evidence of prior Myocardial Infarction defined by either:

    A. Clinical history of prior myocardial infarction OR B. Mild-moderate systolic LV dysfunction with an EF ≤50%

  3. LVEF>35% by any current standard evaluation technique (e.g., echocardiogram, MUGA, angiography).

    • Patients who have an EF between 30-35% and NYHA Class I heart failure who do not have a history of ventricular tachyarrhythmias, or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled (Target Population).

  4. CE-MRI measure of infarct mass > 10% of LV mass (as measured by the MRI core lab)

    • If CE-MRI performed ≤ 40 days after myocardial infarction infarct mass must be ≥ 15% of the LV mass.

  5. Patients aged 18 years or above

    1. CAD will be confirmed by evidence of one of the following three (3) criteria 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery. Patients may not be randomized until 90 days after revascularization.
    2. MI should be documented by the presence of two (2) of the following three (3) criteria: 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab). Patients may not be randomized until 40 days after myocardial infarction.

Exclusion Criteria

  1. History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater)*
  2. Unexplained syncope
  3. Need for revascularization based on investigator's clinical assessment within the next 12 months (patients may be reevaluated 90 days after revascularization)
  4. Currently implanted permanent pacemaker and/or pacemaker/ICD lead
  5. Contraindication to a ICD implant (i.e. inadequate venous access, bleeding disorder)
  6. Acute or chronic severe renal insufficiency (< 30mL/min/1.73m2); acute renal insufficiency of any severity due to hepato-renal syndrome
  7. Current or planned renal or liver transplant
  8. End stage renal disease on hemodialysis or peritoneal dialysis
  9. Contraindication to CE-MRI or history of allergy to gadolinium-based contrast dye
  10. Metal fragments in the eyes or face, implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlear implants or nerve stimulators, surgery on the blood vessels of the brain, body piercing
  11. Recent MI (<40 days) or revascularization (<90 days)
  12. CVA within 90 days
  13. Antiarrhythmic drug therapy for ventricular arrhythmias
  14. New York Heart Association CHF functional class IV at enrollment

Non-Investigational Registry Inclusion Criteria

  • Evidence of CAD a with either a history of prior myocardial infarction OR any LV dysfunction
  • Evidence of LV dysfunction (ejection fraction) as measured by any current standard screening technique (e.g., echocardiogram, MUGA, angiography).c
  • Clinical CE-MRI within the past 12 months (scheduled or completed)
  • Patients aged 18 years or above
  • CAD will be confirmed by evidence of one of the following three (3) criteria 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery.
  • MI should be documented by the presence of two (2) of the following three (3) criteria: 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab).
  • Patients can be enrolled in the registry even if they have received or are about to receive an ICD for primary prevention.

Exclusion Criteria

  • History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120BPM or greater)*
  • Contraindication to CE-MRI or history of allergy to gadolinium-based contrast
  • Spontaneous arrhythmia that precludes assessment by cardiac MRI
  • Acute or chronic severe renal insufficiency (<30mL/min/1.73m2); acute renal insufficiency of any severity due to hepato-renal syndrome.
  • Current or planned renal or liver transplant
  • End stage renal disease on hemodialysis or peritoneal dialysis
  • Metal fragments in the eyes or face, implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlear implants or nerve stimulators, surgery on the blood vessels of the brain , body piercing
  • Uninterpretable MRI images by core lab criteria
  • Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor 6-month survival)
  • Marked valvular heart disease requiring surgical intervention
  • Current alcohol or drug abuse
  • Participating in other trials with an active treatment arm (not to exclude patients who are in trials of diagnostic techniques or approved therapies)
  • Unwilling or unable to provide informed consent *Exception: Cardiac arrest or spontaneous VT that occurs during the acute MI event will not be considered an exclusion

Sites / Locations

  • Alaska Regional Hospital and Alaska Cardiovascular Research Foundation, LLC
  • University of Arizona
  • Glendale Memorial Hospital and Health Center
  • Long Beach Memorial Medical Center
  • Hollywood Presbyterian Medical Center
  • UCLA Medical Center
  • Hoag Memorial Hospital Presbyterian and Radin Inc.
  • Catholic Healthcare West (d/b/a mercy General Hospital) and Regional Cardiology Associates
  • Rocky Mountain Cardiovascular Associates
  • University of Florida-Shands/Jacksonville
  • Orlando Regional Healthcare System
  • Cardiology Consultants of Northwest Florida
  • Emory University
  • Northeast Georgia Heart Center, PC
  • Northwestern University
  • Midwest Heart Foundation
  • Lutheran Hospital of Indiana and Northern Indiana Research Alliance of the Heart Center Medical Group
  • The Care Group
  • Kentucky Heart Institute / King's Daughter
  • Baptist Healthcare System Inc. (d/b/a Central Baptist Hospital)
  • Johns Hopkins
  • MedStar Research Institute (Washington Hospital Center)
  • The Brigham and Women's Hospital Inc.
  • Caritas St. Elizabeth's Medical Center
  • Henry Ford Health System
  • Advanced Cardiac Healthcare (Bronson Methodist Hospital)
  • William Beaumont Hospital
  • Minneapolis Heart Institute Foundation/Abbott NW Hospital
  • Metropolitan Cardiology Consultants (MCC) / Allina Health System (Mercy & Unity Hospitals)
  • University of Nebraska Medical Center
  • Valley Hospital
  • New York Methodist Hospital
  • St. Luke's - Roosevelt Hospital Center
  • Columbia University Medical Center
  • University of Rochester
  • St. Francis Hospital
  • LeBauer Cardiovascular Research Foundation and Moses H. Cone Memorial Hospital
  • University of Maryland Baltimore and Maryland Medical Center
  • University Hospitals of Cleveland
  • MetroHealth Medical Center
  • The Cleveland Clinic Foundation
  • North Ohio Research, Ltd.
  • AHS Hillcrest Medical Center, LLC and Oklahoma Heart Institute
  • Abington Memorial Hospital
  • Lehigh Valley Hospital and Health Network
  • Allegheny-Singer Research Institute
  • University of Pittsburgh Medical Center
  • Stern Cardiovascular Center
  • Centennial Medical Center
  • St. Thomas Research Institute, LLC
  • Vanderbilt Medical Center
  • Methodist Hospital Research Institute
  • St. Luke's Episcopal Hospital
  • Sentara Hospitals and Sentara Cardiovascular Research Institute
  • Cardiovascular Associates Virginia Beach
  • North Cascade Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ICD Group

Control Group

Arm Description

ICD (Implantable Cardioverter Defibrillator)

Medial Therapy

Outcomes

Primary Outcome Measures

All-cause Mortality

Secondary Outcome Measures

Arrhythmic Mortality
Arrhythmic mortality was reported as the number of randomized patients who died due to arrhythmic death. Arrhythmic death was defined as death due to arrhythmia or sudden death.

Full Information

First Posted
June 13, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00487279
Brief Title
DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation
Acronym
DETERMINE
Official Title
DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early due to inability to enroll.
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial is a prospective, multi-center, randomized study of patients with coronary artery disease (CAD) and mild to moderate left ventricular (LV) dysfunction. The primary objective of this study is to test the hypothesis that Implantable Cardioverter Defibrillator (ICD) therapy in combination with medical therapy in patients with an infarct size greater than or equal to 10% of the left ventricular mass improves long term survival compared to medical therapy alone. In addition to the 2-arm randomized trial, the study will also include a non-investigational registry of non-randomized patients.
Detailed Description
Detailed Description: The utilization of ICD therapy has resulted in significant reduction in mortality among those at highest risk of sudden cardiac death, such as survivors of cardiac arrest and patients presenting with symptomatic sustained ventricular arrhythmias. Patients with CAD and advanced LV dysfunction (EF <35%) also benefit from ICD. However, although at high risk, these patients represent only a small percentage of the population who die suddenly. While there are many tests that have been used for stratification of risk for sudden cardiac death, the two that have documented clinical utility are determination of left ventricular ejection fraction and presence of inducibility of ventricular tachycardia during programmed electrical stimulation performed as part of EP testing. The utility of these tests likely result from their ability to select patients who have the requisite substrate allowing for sustained ventricular tachyarrhythmias. It has been shown that ventricular tachycardia occurs more commonly in the setting of larger infarcts. Ejection fraction has been related to infarct size; presumably, the larger the area of infarction, the lower the ejection fraction. Electrophysiologic testing directly establishes the presence of substrate by the actual induction of ventricular tachycardia. A major limitation of electrophysiologic programmed stimulation is the high number of false negative findings. Thus, a significant number of patients without inducible arrhythmias remain at risk. CE-MRI provides functional information (EF, LV Volumes, LV mass, etc), which is routine in the initial evaluation of post-MI patients, and in addition provides detailed geometry of scar tissue. There is a clear association between inducible arrhythmias and scar size which until the development of cardiac MRI, could not be seen in humans. Use of cardiac MRI has demonstrated that although most patients with a large MI were inducible, a small but significant number of patients, who remain at risk, were not inducible. There was also an association between death and infarct size in patients with cardiovascular risk factors but no established CAD. The Center for Medicare Services (CMS) has recently decided in a coverage decision that patients with left ventricular dysfunction, heart failure, and an ejection fraction of <35% would be eligible to receive an ICD as long as they are enrolled in a prospective registry. Patients with LV ejection fractions greater than 35% or those without heart failure and ejection fractions over 30%, represent a more difficult management dilemma. However, since the majority of out of hospital cardiac arrests occur in patients with EF >35%, managing these patients is crucial in addressing the epidemiologic problem of sudden cardiac death. The primary objective of this trial is to test the hypothesis that therapy with an ICD combined with medical therapy improves long-term survival compared to medical therapy alone in patients with CAD, infarct mass greater than or equal to 10% of the left ventricle and left ventricular dysfunction who do not have an indication for ICD by either of the following criteria. Patients must have an EF of >35% or have an EF of 30-35% and must not have inducible ventricular tachycardia or have NYHA Class II or greater heart failure (Target Population). The secondary objective is to test the hypothesis that therapy with an ICD combined with medical therapy improves arrhythmic survival compared to medical therapy alone in patients with CAD, infarct mass greater than or equal to 10% and left ventricular dysfunction who do not have an indication for ICD based on the Target Population described above. Recruitment: All patients who have a history of coronary heart disease (CAD) with documentation of either myocardial infarction (MI) or left ventricular dysfunction (LVD), a preliminary ejection fraction (EF) > 35% and have previously undergone a contrast-enhanced MRI (CE-MRI) study for clinical diagnostic reasons or as part of the study entry screening procedure may be further evaluated for eligibility for this trial. In addition, patients with an ejection fraction of 30-35% may be eligible for the study if they do not currently have an indication for an ICD based on Target Population criteria described above. These patients may have NYHA Class I heart failure, no non-sustained VT on holter monitor, or if non-sustained VT is present, there is the absence of inducible VT at EP study. The first 1550 patients who are found to have an EF >30% with NYHA Class I heart failure or 35% by routine clinical evaluation and who also have an MI involving greater than or equal to 10% of total left ventricular mass will be enrolled in the main randomized portion of the trial. These patients will be randomly assigned to one of two groups: ICD therapy in combination with medical therapy (ICD Group) or medical therapy alone (Control Group). Follow-Up: Clinic visits are required every 6 months until the completion of the study. Telephone contact is required every six months to assess vital status and obtain new information regarding medical status and/or medical events. The telephone calls alternate with the clinical visits, so that patient contact will occur every 3 months until the completion of the study. Non-Investigational Registry: The primary objective of the registry sub-study is to test the hypothesis that infarct mass as measured by contrast enhanced Cardiac MRI (CE-MRI) is a better predictor for sudden cardiac death than LV ejection fraction. The registry will examine infarct mass as measured by Cardiac MRI and LV ejection fraction (EF) as predictors for SCD. The purpose of the registry is hypothesis generating and no labeling or other indications are anticipated based on registry findings. Participation in the Registry requires that the patient has undergone a contrast-enhanced cardiac MRI prior to enrollment. In order to ensure consistent infarct mass assessments, the cardiac MRI study submitted to determine eligibility for randomization must meet the following criteria: CE-cardiac MRIs must be obtained using Siemens, General Electric or Phillips equipment. The contrast agent must be gadolinium-based at a dose sufficient to render images of acceptable quality. The CE-cardiac MRI must be available for electronic submission to the MRI Core laboratory for analysis. If techniques for infarct mass measurement or data acquisition change during the course of the trial, the Core laboratory and the Steering Committee may choose to alter some of the above parameters. Once consent to participate in the registry has been obtained, the site will forward the CE-MRI study to the CE-MRI core lab for analysis to determine placement in the appropriate registry, baseline demographics characteristics will be collected on all registry patients. This will aid in statistical analysis to verify the generalizability of the findings. The differences in total survival between these groups will also be compared using the same methodology as for the primary end-point. Patients with and without ICD implants will be compared separately. In addition, blood specimens for genetic sampling and biomarker testing will be obtained on all patients in the registry cohort who agree, to determine if any of SCD substrates exist in the DETERMINE registry population. Study subjects will be contacted by mail by the Endpoint Coordinating Center at Brigham and Women's Hospital in Boston every 6 months to determine vital status and obtain any new information regarding change in medical status or the occurrence of any medical events. This will promote the continued relationship between the study participant and the enrolling center and can also be used to remind the study subject of their next scheduled appointment. Scope and Duration of the trial: Up to 100 sites to screen a total of 10,000 patients will enroll 1550 patients into the randomized study recruited from a total of 10,000 patients contributing data and CE-MRI images to the registries. Registry enrollment per site = ~90 subjects Randomization per site = 1-3 per month (expected randomized enrollment per site is 20 patients or more ) Estimated enrollment period: 36 months 24 months of follow-up after the last patient is randomized

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Left Ventricular Dysfunction, Sudden Cardiac Death
Keywords
Coronary, Artery, Disease, Sudden, Cardiac, Death, ICD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICD Group
Arm Type
Experimental
Arm Description
ICD (Implantable Cardioverter Defibrillator)
Arm Title
Control Group
Arm Type
Other
Arm Description
Medial Therapy
Intervention Type
Device
Intervention Name(s)
Defibrillator
Other Intervention Name(s)
Implantable Cardioverter Defibrillator
Intervention Description
ICD(Implantable Cardioverter Defibrillator)
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
No Intervention
Intervention Description
No Intervention
Primary Outcome Measure Information:
Title
All-cause Mortality
Time Frame
Total survival will be evaluated 2 years after the last patient is randomized.
Secondary Outcome Measure Information:
Title
Arrhythmic Mortality
Description
Arrhythmic mortality was reported as the number of randomized patients who died due to arrhythmic death. Arrhythmic death was defined as death due to arrhythmia or sudden death.
Time Frame
Total survival will be evaluated 2 years after the last patient is randomized.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Randomized Arm Evidence of Coronary Artery Disease (CAD)a. Evidence of prior Myocardial Infarction defined by either: A. Clinical history of prior myocardial infarction OR B. Mild-moderate systolic LV dysfunction with an EF ≤50% LVEF>35% by any current standard evaluation technique (e.g., echocardiogram, MUGA, angiography). • Patients who have an EF between 30-35% and NYHA Class I heart failure who do not have a history of ventricular tachyarrhythmias, or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled (Target Population). CE-MRI measure of infarct mass > 10% of LV mass (as measured by the MRI core lab) • If CE-MRI performed ≤ 40 days after myocardial infarction infarct mass must be ≥ 15% of the LV mass. Patients aged 18 years or above CAD will be confirmed by evidence of one of the following three (3) criteria 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery. Patients may not be randomized until 90 days after revascularization. MI should be documented by the presence of two (2) of the following three (3) criteria: 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab). Patients may not be randomized until 40 days after myocardial infarction. Exclusion Criteria History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater)* Unexplained syncope Need for revascularization based on investigator's clinical assessment within the next 12 months (patients may be reevaluated 90 days after revascularization) Currently implanted permanent pacemaker and/or pacemaker/ICD lead Contraindication to a ICD implant (i.e. inadequate venous access, bleeding disorder) Acute or chronic severe renal insufficiency (< 30mL/min/1.73m2); acute renal insufficiency of any severity due to hepato-renal syndrome Current or planned renal or liver transplant End stage renal disease on hemodialysis or peritoneal dialysis Contraindication to CE-MRI or history of allergy to gadolinium-based contrast dye Metal fragments in the eyes or face, implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlear implants or nerve stimulators, surgery on the blood vessels of the brain, body piercing Recent MI (<40 days) or revascularization (<90 days) CVA within 90 days Antiarrhythmic drug therapy for ventricular arrhythmias New York Heart Association CHF functional class IV at enrollment Non-Investigational Registry Inclusion Criteria Evidence of CAD a with either a history of prior myocardial infarction OR any LV dysfunction Evidence of LV dysfunction (ejection fraction) as measured by any current standard screening technique (e.g., echocardiogram, MUGA, angiography).c Clinical CE-MRI within the past 12 months (scheduled or completed) Patients aged 18 years or above CAD will be confirmed by evidence of one of the following three (3) criteria 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery. MI should be documented by the presence of two (2) of the following three (3) criteria: 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab). Patients can be enrolled in the registry even if they have received or are about to receive an ICD for primary prevention. Exclusion Criteria History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120BPM or greater)* Contraindication to CE-MRI or history of allergy to gadolinium-based contrast Spontaneous arrhythmia that precludes assessment by cardiac MRI Acute or chronic severe renal insufficiency (<30mL/min/1.73m2); acute renal insufficiency of any severity due to hepato-renal syndrome. Current or planned renal or liver transplant End stage renal disease on hemodialysis or peritoneal dialysis Metal fragments in the eyes or face, implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlear implants or nerve stimulators, surgery on the blood vessels of the brain , body piercing Uninterpretable MRI images by core lab criteria Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor 6-month survival) Marked valvular heart disease requiring surgical intervention Current alcohol or drug abuse Participating in other trials with an active treatment arm (not to exclude patients who are in trials of diagnostic techniques or approved therapies) Unwilling or unable to provide informed consent *Exception: Cardiac arrest or spontaneous VT that occurs during the acute MI event will not be considered an exclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Kadish, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Regional Hospital and Alaska Cardiovascular Research Foundation, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Glendale Memorial Hospital and Health Center
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Hollywood Presbyterian Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian and Radin Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92263
Country
United States
Facility Name
Catholic Healthcare West (d/b/a mercy General Hospital) and Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95818
Country
United States
Facility Name
Rocky Mountain Cardiovascular Associates
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
University of Florida-Shands/Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Orlando Regional Healthcare System
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Cardiology Consultants of Northwest Florida
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30365
Country
United States
Facility Name
Northeast Georgia Heart Center, PC
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Midwest Heart Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Lutheran Hospital of Indiana and Northern Indiana Research Alliance of the Heart Center Medical Group
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
The Care Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Kentucky Heart Institute / King's Daughter
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Baptist Healthcare System Inc. (d/b/a Central Baptist Hospital)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
MedStar Research Institute (Washington Hospital Center)
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20783
Country
United States
Facility Name
The Brigham and Women's Hospital Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Advanced Cardiac Healthcare (Bronson Methodist Hospital)
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Minneapolis Heart Institute Foundation/Abbott NW Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Metropolitan Cardiology Consultants (MCC) / Allina Health System (Mercy & Unity Hospitals)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
St. Luke's - Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
LeBauer Cardiovascular Research Foundation and Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
University of Maryland Baltimore and Maryland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
21201
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
North Ohio Research, Ltd.
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
AHS Hillcrest Medical Center, LLC and Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Lehigh Valley Hospital and Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Allegheny-Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Stern Cardiovascular Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
St. Thomas Research Institute, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara Hospitals and Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Cardiovascular Associates Virginia Beach
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
North Cascade Cardiology
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States

12. IPD Sharing Statement

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DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation

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