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
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