Trials / Completed
CompletedNCT00848835
Long Term Integrity Follow-up Evaluation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 372 (actual)
- Sponsor
- Guidant Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | defibrillation lead (ENDOTAK EZ and RELIANCE) | defibrillation lead |
Timeline
- Start date
- 2002-03-01
- Primary completion
- 2009-10-01
- Completion
- 2010-01-01
- First posted
- 2009-02-20
- Last updated
- 2010-08-31
Source: ClinicalTrials.gov record NCT00848835. Inclusion in this directory is not an endorsement.