NCT00733590Recruiting
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 11 Aug 2008
- Start date
- Jun 2003
- Primary completion date
- Mar 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Heart failure
- NCT number
- NCT00733590
What you commit to
- Study type: Observational
- Planned participants: 1500
- From Jun 2003 to the primary completion date, Mar 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with pre-existing Class 1 indications for pacemaker therapy.
Other illness
- New York Heart Association Class IV heart failure
Other
- ICD generator replacement for secondary prevention
- Inability or unwillingness to provide valid informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Johns Hopkins University School Of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Virginia Commonwealth University School of Medicine Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
Related publications
- Combined Analysis of Cardiac Repolarization Entropy and Magnetic Resonance Imaging Enhances Risk Stratification of Patients Receiving a Primary-Prevention ICD.JACC Clin Electrophysiol · 2026 · PMID 41823943
This page is information, not medical advice. Discuss any trial with your doctor.