Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

RecruitingObservational study

Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)

Who can join

Ages 18 to 85 · All sexes

Full eligibility criteria

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.

About the study

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

Sponsor: Johns Hopkins University · Participants: 1,500 · Started: 2003-06

Contact the study team

Katherine Wu, MD · Phone: 410-502-7283

Official record on ClinicalTrials.gov — NCT00733590

Locations in the U.S.

District of Columbia	Washington Hospital Center, Washington D.C.
Maryland	Johns Hopkins University School of Medicine, Baltimore University of Maryland Medical Center, Baltimore
Virginia	Virginia Commonwealth University School of Medicine, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.