Status:
COMPLETED
Long Term Integrity Follow-up Evaluation
Lead Sponsor:
Guidant Corporation
Conditions:
Sudden Cardiac Death
Eligibility:
All Genders
18+ years
Brief Summary
To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.
Detailed Description
There are few prospective long term follow-up studies on implanted cardiac device (pacemaker/implantable cardioverter defibrillator (ICD)) survivability. This study will evaluate the long term perform...
Eligibility Criteria
Inclusion
- Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals
Exclusion
- Patients enrolled in other studies, not available for follow-up, \< 18 yrs, unable to sign consent, life expectancy \< 1 year due to a medical condition
Key Trial Info
Start Date :
March 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT00848835
Start Date
March 1 2002
End Date
January 1 2010
Last Update
August 31 2010
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