Trials / Completed
CompletedNCT01361672
Model 4296 Left Ventricular (LV) Lead Chronic Performance Study
Attain Ability® Family Left Ventricular Lead Chronic Performance Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,140 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Lead survivability will be summarized.
Detailed description
The purpose of this study is to evaluate long-term performance of the 4296 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 4296 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
Conditions
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2019-07-01
- Completion
- 2019-07-01
- First posted
- 2011-05-27
- Last updated
- 2019-07-22
Locations
99 sites across 3 countries: United States, Canada, Germany
Source: ClinicalTrials.gov record NCT01361672. Inclusion in this directory is not an endorsement.