Model 4195 Left Ventricular (LV) Lead Chronic Performance Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:9/15/2018
Start Date:March 2009
End Date:April 3, 2018

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Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study

Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of
lead-related complications occuring 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 4195 LV Lead and is integrated within Medtronic's
post-market surveillance platform.

Model 4195 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 StarFix Model 4195 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
63
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Colorado Springs, Colorado 80910
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