Model 4296 Left Ventricular (LV) Lead 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:May 2011
End Date:July 2019

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Attain Ability® Family Left Ventricular Lead Chronic Performance Study

Lead survivability will be summarized.

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.

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 4296 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
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Colorado Springs, Colorado 80910
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Greensboro, North Carolina 27401
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