Trials / Completed
CompletedNCT00869921
Model 4195 Left Ventricular (LV) Lead Chronic Performance Study
Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,322 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring 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 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.
Detailed description
Model 4195 LV lead complication-free survivability will be summarized.
Conditions
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2018-04-03
- Completion
- 2018-04-03
- First posted
- 2009-03-26
- Last updated
- 2018-09-13
Locations
67 sites across 3 countries: United States, Canada, United Kingdom
Source: ClinicalTrials.gov record NCT00869921. Inclusion in this directory is not an endorsement.