Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention
Recruiting · NCT00733590 · Observational (researchers observe without assigning treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →What this trial is about
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
Who can take part
Inclusion criteria
- 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.
- Who have primary prevention implants.
Exclusion criteria
- 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.
Where it is running
4 locations listed across 3 US states.
- Washington Hospital Center - Washington D.C., District of Columbia, United States
- University of Maryland Medical Center - Baltimore, Maryland, United States
- Johns Hopkins University School of Medicine - Baltimore, Maryland, United States
- Virginia Commonwealth University School of Medicine - Richmond, Virginia, United States