Status:

COMPLETED

Assessment of Appropriate ICD Implantation for Primary Prevention of Sudden Cardiac Death

Lead Sponsor:

University of Minnesota Physicians Heart at Fairview

Collaborating Sponsors:

Boston Scientific Corporation

Conditions:

Cardiomyopathies

Eligibility:

All Genders

18+ years

Brief Summary

Prophylactic implant of an ICD (implantable cardioverter defibrillator) for prevention of sudden cardiac death from a life-threatening heart rhythm abnormality is a standard recommendation for patient...

Detailed Description

The implantable cardioverter defibrillator (ICD) for patients at high risk of sudden cardiac death (primary prevention) has become an accepted therapy after multiple randomized trials demonstrated the...

Eligibility Criteria

Inclusion

  • Age 18 years or older
  • Ejection fraction of 35% or less by echocardiogram and/or cardiac nuclear scan

Exclusion

  • Age less than 18 years
  • Patients currently enrolled in a clinical trial that would be impacted by receipt of an ICD
  • Pregnant women

Key Trial Info

Start Date :

March 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2010

Estimated Enrollment :

549 Patients enrolled

Trial Details

Trial ID

NCT00926159

Start Date

March 1 2008

End Date

November 1 2010

Last Update

August 4 2011

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