Studies heart defibrillator patients to understand sudden cardiac death risk
Observes adults with heart disease receiving a defibrillator replacement to study sudden death risk.
Plain-language title generated from the registry record
Registry title: Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention
Key facts
- Where
- Baltimore, Richmond, and Washington D.C., United StatesSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT00733590, who can take part
Where in United States
- Johns Hopkins University School Of MedicineBaltimore, United StatesTaking people
- University of Maryland Medical CenterBaltimore, United StatesTaking people
- Virginia Commonwealth University School of MedicineRichmond, United StatesTaking people
- Washington Hospital CenterWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johns Hopkins University
- Trial code
- NCT00733590
- Record updated
- 20 January 2026
- Original description
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 :Read full original descriptionShow less
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)
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
Inclusion: 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: Patients with pre-existing Class 1 indications for pacemaker therapy; New York Heart Association Class IV heart failure; ICD generator replacement for secondary prevention; Inability or unwillingness to provide valid informed consent.