NCT00869921
Completed
Not Applicable
Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
ConditionsHeart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic
- Enrollment
- 1322
- Primary Endpoint
- Lead-related complication rate.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Lead-related complication rate.
Time Frame: Implant to 5 years post-implant.
Secondary Outcomes
- Types of Model 4195 lead-related events(5 years post implant)
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