Trials / Completed
CompletedNCT00930904
Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,847 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).
Detailed description
Model 4196 LV lead complication-free survivability will be summarized.
Conditions
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2017-04-01
- Completion
- 2017-04-01
- First posted
- 2009-07-02
- Last updated
- 2017-12-27
Locations
103 sites across 8 countries: United States, Austria, Belgium, Canada, France, Italy, Netherlands, Spain
Source: ClinicalTrials.gov record NCT00930904. Inclusion in this directory is not an endorsement.