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NCT00848835 Clinical Trial

Long Term Integrity Follow-up Evaluation

Sudden Cardiac Death Clinical Trial

— LEAD LIFE  

Official title:
Long Term Integrity Follow-up Evaluation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00848835
Other study ID # LEAD LIFE
Secondary ID
Status Completed
Phase Phase 4
First received February 19, 2009
Last updated August 30, 2010
Start date March 2002
Est. completion date January 2010

Study information
Verified date August 2010
Source Guidant Corporation
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 372
Est. completion date January 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Guidant Corporation
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