Model 4296 Left Ventricular (LV) Lead Chronic Performance Study
- Conditions
- Heart Failure
- Registration Number
- NCT01361672
- Lead Sponsor
- Medtronic
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1140
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Model 4296 LV Lead-related complication rate 5 years To demonstrate that the Model 4296 lead-related complication-free probability
- Secondary Outcome Measures
Name Time Method Number of fractures with and without loss of function 5 years To characterize fractures with and without loss of function
Types of lead-related adverse device effects 5 years To summarize all lead related adverse events
Percent of subjects with changes in electrode programming 5 years To characterize any changes in electrical programming
Bipolar electrical performance at 1 year 1 year To summarize bipolar electrical performance at one year post implant
Bipolar pacing impedance 1 year To characterize threshold measurements and impedance for both conductors
Bipolar pacing capture threshold 1 year To characterize standard bipolar pacing voltage thresholds