About this trial

The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to :

1. to gain a better understanding of the biological mechanisms that predispose to SCD 2. to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly

Eligibility criteria

Qualifiers

History of acute MI at least 4 weeks old

Non-ischemic LV dysfunction for at least 9 months

Who have an ejection fraction (EF) < or = to 35%

Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.

Disqualifiers

ICD generator replacement for secondary prevention

Inability or unwillingness to provide valid informed consent

New York Heart Association Class IV heart failure

Patients with pre-existing Class 1 indications for pacemaker therapy.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

4
Washington Hospital Center20010, Washington D.C.District of Columbia, United States
Johns Hopkins University School of Medicine21205, BaltimoreMaryland, United States
University of Maryland Medical Center21201, BaltimoreMaryland, United States
Virginia Commonwealth University School of Medicine23298, RichmondVirginia, United States

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

University of Maryland, Baltimore

Collaborator

Medstar Health Research Institute

Collaborator

Virginia Commonwealth University

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator