Model 4396 Left Ventricular (LV) Lead Chronic Performance Study



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:9/20/2018
Start Date:May 2011
End Date:May 2021

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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 4396 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 4396 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 4396 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
61
sites
Rancho Mirage, California 92270
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Albuquerque, New Mexico 87106
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Alexandria, Louisiana 71301
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Allentown, Pennsylvania 18105
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Allentown, PA
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Austin, TX
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5000 Hennessy Boulevard
Baton Rouge, Louisiana 70808
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Baton Rouge, LA
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Bethlehem, Pennsylvania 18017
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Bethlehem, PA
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Bradenton, Florida 34205
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Burlington, Vermont 05405
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Cincinnati, Ohio 45267
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Columbus, Ohio 43214
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Columbus, OH
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Coon Rapids, Minnesota 55433
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Coon Rapids, MN
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Erie, Pennsylvania 16507
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Erie, PA
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801 Broadway
Fargo, North Dakota 58102
(701) 234-6175
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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Gilbert, Arizona 85295
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Greensboro, North Carolina 27401
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Henderson, Nevada 89052
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Indianapolis, IN
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Jacksonville, Florida 32207
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Kansas City, Missouri 64111
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Kingsport, Tennessee 37660
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Kingston,
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Lakewood, Colorado 80228
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Lexington, Kentucky 40503
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Little Rock, Arkansas
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Louisville, Kentucky 40207
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Melbourne, FL
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Milwaukee, Wisconsin 53215
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Minneapolis, Minnesota 55407
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Nashville, Tennessee 37205
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10016
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Phoenix, Arizona 85006
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Plano, Texas 75093
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Raleigh, North Carolina 27610
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Redding, California 96001
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Redding, CA
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Robbinsdale, MN
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Saint Louis, Missouri 63110
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6000 Bass Lake Road
Saint Louis Park, Minnesota 55416
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San Antonio, Texas 78229
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San Antonio, Texas 78258
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San Francisco, CA
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The Woodlands, Texas 77384
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2213 Cherry Street
Toledo, Ohio 43608
(419) 251-3232
Saint Vincent Mercy Medical Center Mercy St. Vincent Medical Center, established in 1855, is the...
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520 North Prospect Avenue
Torrance, California 90503
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Utica, New York 13501
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Van Nuys, California 91405
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Washington, District of Columbia 20010
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Washington, Missouri 63090
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West Des Moines, Iowa 50266
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West Orange, New Jersey 07052
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Wilkes-Barre, Pennsylvania 18711
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Ypsilanti, Michigan 48197
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