Trials / Completed
CompletedNCT02294331
Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study
Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,900 (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 Attain Performa™ LV Leads. 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 Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market surveillance platform.
Conditions
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2021-07-31
- Completion
- 2021-07-31
- First posted
- 2014-11-19
- Last updated
- 2022-02-01
Locations
100 sites across 8 countries: United States, Belgium, Canada, France, Germany, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02294331. Inclusion in this directory is not an endorsement.