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SCD-HeFT 10 Year Follow-up

NCT01058837 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1855

Last updated 2010-02-11

No results posted yet for this study

Summary

No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD) therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer than a few years. The NHLBI sponsored and placebo-controlled Sudden Cardiac Death in heart Failure Trial (SCD-HeFT) conducted from 1997 to 2003 had the largest number of patients and the longest average follow-up at 45.5 months. This study changed the national reimbursement policy for ICD therapy and remains the reference point for all other ICD evaluations in patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction. Despite the outcome, the role of ICD therapy in the management of patients with heart failure has been questioned because of four principal concerns: numbers needed to treat to save a life, lead integrity over time, the negative consequences of shock therapy, and the cost of therapy. The purpose of this trial is to track down the remaining patients for a one-time follow-up regarding key outcome data.

Conditions

  • Left Ventricular Systolic Dysfunction
  • Congestive Heart Failure
  • Ischemic and Non-ischemic Cardiomyopathy
  • Sudden Cardiac Death Primary Prevention

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Seattle Institute for Cardiac Research

    lead OTHER

Principal Investigators

  • Gust H. Bardy, MD · Seattle Institute for Cardiac Research

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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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 NCT01058837 on ClinicalTrials.gov