Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 9/27/2018 |
Start Date: | August 2014 |
End Date: | July 2022 |
Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study
Lead survivability will be summarized.
The purpose of this study is to evaluate long-term performance of the Attain Performa™ LV
Leads. 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
Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market
surveillance platform.
Leads. 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
Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market
surveillance platform.
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 Performa™ 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
95
sites
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