Destination Therapy Post Approval Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:October 31, 2018
End Date:November 2025
Contact:DT PAS Manager
Email:samantha.ly@medtronic.com
Phone:508-532-4722

Use our guide to learn which trials are right for you!

Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study
(PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device
System (HVAD System) when used as intended, in "real-world" clinical practice.

The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product
Surveillance Platform.

The HeartWare Destination Therapy (DT) Post Approval Study (PAS) is a prospective,
observational, multi-site study. Enrollment into the DT PAS will be comprised of newly
enrolled, commercial use DT patients with the HeartWare Ventricular Assist Device System
(HVAD System). Patients enrolled in DT PAS will be followed for 5 years post-implant or until
study closure, patient death, patient exit from the PAS (i.e., withdrawal of consent), or
patient has HVAD device removed without replacement (i.e., transplant, recovery) or device is
exchanged for non-HVAD. The total estimated study duration is approximately 7 years.

Inclusion Criteria:

- Patient or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements

- Patient is intended to receive or be treated with a HeartWare HVAD System for use as
destination therapy

- Patient is consented prior to the HVAD implant procedure

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 (i.e., no required intervention that could
affect interpretation of all-around product safety and or effectiveness)
We found this trial at
17
sites
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Seattle, WA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Aurora, Colorado 80045
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Aurora, CO
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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Cincinnati, Ohio 45219
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Cincinnati, OH
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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Houston, TX
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Indianapolis, Indiana 46260
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from
Indianapolis, IN
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Norfolk, VA
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Oak Lawn, IL
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Orlando, Florida 32804
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Orlando, FL
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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San Francisco, CA
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Stanford, California 94303
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Stanford, CA
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Washington, District of Columbia
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Washington,
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