Long Term Integrity Follow-up Evaluation

Completed

• Conditions: Sudden Cardiac Death
• Interventions: Device: defibrillation lead (ENDOTAK EZ and RELIANCE)

• Registration Number: NCT00848835
• Lead Sponsor: Guidant Corporation

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 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.

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2009-10
• Study Completion: 2010-01
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-30
• Last Update Posted: 2010-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	defibrillation lead (ENDOTAK EZ and RELIANCE)	all patients in the control group