Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/29/2017 |
| Start Date: | June 2009 |
| End Date: | April 2017 |
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).
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
- Patient or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements
- Patient has or is intended to receive an Attain Ability Model 4196 LV lead
- Patient within 30 day post implant enrollment window
Exclusion Criteria
- Patient who is, or is expected to be inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or
device study that may confound results
We found this trial at
92
sites
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