Long Term Integrity Follow-up Evaluation (LEAD LIFE)

Guidant

Status: Completed

Conditions: Sudden Cardiac Death

Treatments: Device: defibrillation lead (ENDOTAK EZ and RELIANCE)

Study type: Observational

Funder types: Industry

Identifiers

NCT00848835

LEAD LIFE

Details and patient eligibility

About

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

Full 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.

Enrollment: 372 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

372 participants in 1 patient group

control

Description:

all patients in the control group

Treatment:

Device: defibrillation lead (ENDOTAK EZ and RELIANCE)