Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Johns Hopkins University
Study ID
NCT00733590
Status
Recruiting
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Conditions

  • Arrhythmia
  • Cardiomyopathies
  • Death, Sudden, Cardiac
  • Heart Failure, Congestive

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

Start date
Jun 30, 2003
Status verified
Jan 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
1,500 participants (estimated)

Primary Outcome Measure

Arrhythmic Sudden Death defined as a therapy from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD [ Time Frame: 10 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Washington Hospital CenterWashington D.C.District of Columbia20010
Zayd Eldadah, MD, PhD
[email protected]
202-877-7865
Johns Hopkins University School of MedicineBaltimoreMaryland21205
Katherine Wu, MD
[email protected]
410-502-7283
University of Maryland Medical CenterBaltimoreMaryland21201
Stephen R Shorofsky, MD, PhD
[email protected]
800-492-5538
Virginia Commonwealth University School of MedicineRichmondVirginia23298
Kenneth Ellenbogen, MD
[email protected]
804-828-7576

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By research site
Washington Hospital Center· Washington D.C., DCJohns Hopkins University School of Medicine· Baltimore, MDUniversity of Maryland Medical Center· Baltimore, MDVirginia Commonwealth University School of Medicine· Richmond, VA

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