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Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

NCT00733590 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-01-20

No results posted yet for this study

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 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

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

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • Medstar Health Research Institute

    collaborator OTHER

  • Virginia Commonwealth University

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Katherine C Wu, MD · Associate Professor of Medicine Johns Hopkins University

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2028-03-31
Completion
2029-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00733590 on ClinicalTrials.gov