Personalized CRT - MPP Post Approval Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:8/19/2018
Start Date:July 5, 2017
End Date:July 5, 2020
Contact:MPP PAS Study Team
Email:rs.productsurveillanceregistry@medtronic.com
Phone:1-800-633-8766

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Personalized CRT - Multiple Point Pacing Post Approval Study

The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to
improve CRT response in the non-responder patient population when used in "real-world"
clinical practice, following commercial release. This evaluation is based on the Clinical
Composite Score which summarizes the proportions and frequencies of CRT non-responder
patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients
will be followed for the duration of the PAS. This study is required by FDA as a condition of
approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).


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 or be treated with an eligible CRT device

- Patient within 30 days of therapy received at the time of their initial PSR platform
enrollment

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
42
sites
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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Cincinnati, OH
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Akron, OH
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Albany, Georgia 31701
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Albany, GA
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Albuquerque, New Mexico 87106
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Allentown, Pennsylvania 18105
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Allentown, PA
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Austin, TX
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Baltimore, Maryland 21237
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Burlington, Vermont 05405
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Chula Vista, California 91910
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Chula Vista, CA
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Cincinnati, Ohio 45267
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Colorado Springs, Colorado 80907
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Colorado Springs, CO
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Columbia, MO
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Garden City, New York 11530
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Henderson, Nevada 89052
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Huntington, New York 11743
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Jacksonville, Florida
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Lakewood, Colorado 80228
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Lakewood, CO
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Leuven,
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Little Rock, Arkansas
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Marquette, Michigan 49855
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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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1100 North Palm Canyon Drive
Palm Springs, California 92262
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Poughkeepsie, New York 12601
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Raleigh, North Carolina 27610
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Raleigh, NC
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Robbinsdale, MN
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Rochester, Minnesota 55905
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Rochester, MN
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1840 Mease Drive
Safety Harbor, Florida 34695
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salisbury, Maryland 21804
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122 West 7th Avenue
Spokane, Washington 99204
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Toledo, OH
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520 North Prospect Avenue
Torrance, California 90503
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Utica, New York 13501
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Wilkes-Barre, Pennsylvania 18711
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Ypsilanti, Michigan 48197
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