Long Term Integrity Follow-up Evaluation

Long Term Integrity Follow-up Evaluation

To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.

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 performance (5 years) of the transvenous defibrillation leads (ENDOTAK ENDURANCE EZ and teh ENDOTAK RELIANCE. Data will be collected at implant, 1 and 6 months, 1,3 and 5 years.

Inclusion Criteria:

• Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals

Exclusion Criteria:

• 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