Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT00930904
- Lead Sponsor
- Medtronic
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1847
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lead-related complication rate 5 years
- Secondary Outcome Measures
Name Time Method Types of lead-related events 5 years Percent of subjects with changes in electrode programming 5 Years Percent of fractures with loss of function 5 years Mean bipolar pacing threshold 1 year Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations 1 year