Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study
Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study
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).
Model 4196 LV lead complication-free survivability will be summarized.
Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
Inclusion Criteria
Exclusion Criteria
Ste-Foy, Quebec, Canada