Status:
RECRUITING
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
University of Maryland, Baltimore
Medstar Health Research Institute
Conditions:
Heart Failure, Congestive
Death, Sudden, Cardiac
Eligibility:
All Genders
18-85 years
Brief Summary
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 us...
Detailed Description
PROSe-ICD is a multicenter prospective cohort study of patients who undergo ICD implantation for primary prevention of SCD, designed to compare patients who sustain SCD (as measured by an appropriate ...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00733590
Start Date
June 1 2003
End Date
March 1 2029
Last Update
January 14 2025
Active Locations (4)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
3
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
4
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States, 23298