Trials / Completed
CompletedNCT01361685
Model 4396 Left Ventricular (LV) Lead Chronic Performance Study
Attain Ability® Family Left Ventricular Lead Chronic Performance Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 366 (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 4396 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 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
Conditions
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2020-03-02
- Completion
- 2021-02-04
- First posted
- 2011-05-27
- Last updated
- 2021-02-17
Locations
52 sites across 3 countries: United States, Canada, Germany
Source: ClinicalTrials.gov record NCT01361685. Inclusion in this directory is not an endorsement.