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
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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Albuquerque, New Mexico 87106
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Alexandria, Louisiana 71301
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Allentown, Pennsylvania 18105
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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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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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Coon Rapids, Minnesota 55433
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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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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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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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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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Rancho Mirage, California 92270
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Redding, California 96001
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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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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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