Long Term Integrity Follow-up Evaluation

Guidant Corporation372 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

372

Conditions

Sudden Cardiac Death

Interventions

defibrillation lead (ENDOTAK EZ and RELIANCE)DEVICE

defibrillation lead

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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