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

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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

- 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
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Alexandria, LA
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Akron, OH
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Browns Mills, NJ
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Burlington, VT
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Charleston, South Carolina 29412
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Chattanooga, TN
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Chula Vista, CA
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Clearwater, FL
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Colorado Springs, Colorado 80910
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Columbia, MO
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Greensboro, North Carolina 27401
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