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Clinical trial Recruiting at 4 sites Observational Ages 18 to 85

Observational study on heart defibrillators for preventing sudden cardiac death

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

Run by Johns Hopkins University · NCT00733590 · Data updated 2026-11-12

This study looks at patients with heart defibrillators to see what factors might increase the risk of sudden cardiac death and how to better choose who needs these devices.

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment1500 (estimated)
SponsorJohns Hopkins University
Academic / other
Locations4 sites (Washington D.C., District of Columbia and 3 other locations)
StatusRecruiting
StartedJune 2003
Main results expectedMarch 2028
Study endsMarch 2029
Registry record updatedJanuary 20, 2026
Trial IDNCT00733590 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with a history of acute myocardial infarction, non-ischemic left ventricular dysfunction, and an ejection fraction of 35% or less who are undergoing ICD generator replacement for primary prevention.

Probably not a fit

Patients with secondary prevention ICD replacements or those with advanced heart failure (NYHA Class IV) may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to understand the biological mechanisms that lead to sudden cardiac death (SCD) by examining patients with implanted internal defibrillators (ICDs) for primary prevention. It will categorize and follow these patients to identify clinical, electrocardiographic, genetic, and blood protein markers that indicate an increased risk of SCD. The study will compare patients who experience SCD events to those who do not, using standardized ICD settings to facilitate rhythm identification. The goal is to improve patient selection for ICD therapy based on their risk profiles.

Why it matters

Potential benefit: If successful, this study could lead to better identification of patients who would benefit from ICD implantation, potentially reducing the incidence of sudden cardiac death.

How similar studies have gone: Other studies have shown success in identifying risk factors for sudden cardiac death, making this approach both relevant and potentially impactful.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

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

Study contacts

  • Principal investigator: Katherine C Wu, MD — Associate Professor of Medicine Johns Hopkins University
  • Study coordinator: Katherine Wu, MD
  • Email: kwu@jhmi.edu
  • Phone: 410-502-7283

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.