Actively Recruiting
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention
Led by Johns Hopkins University · Updated on 2026-01-20
1500
Participants Needed
4
Research Sites
1343 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
U
University of Maryland, Baltimore
Collaborating Sponsor
AI-Summary
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
CONDITIONS
Official Title
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of acute myocardial infarction at least 4 weeks old
- Non-ischemic left ventricular dysfunction for at least 9 months
- Ejection fraction of 35% or less
- Elective replacement indicator generator replacement of an FDA-approved ICD for primary prevention of sudden cardiac death within 24 months prior to enrollment
- Primary prevention ICD implants
You will not qualify if you...
- ICD generator replacement for secondary prevention
- Unable or unwilling to provide valid informed consent
- New York Heart Association Class IV heart failure
- Patients with existing Class 1 indications for pacemaker therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
4
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
K
Katherine Wu, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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