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NCT03681210Active, not recruiting

Destination Therapy Post Approval Study

Source: ClinicalTrials.gov · Last updated 22 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
300 (actual)
First submitted
20 Sept 2018
Start date
31 Oct 2018
Primary completion date
Apr 2026
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
NCT number
NCT03681210

What you commit to

  • Study type: Observational
  • Participants enrolled: 300
  • From 31 Oct 2018 to the primary completion date, Apr 2026
  • 47 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Patient with previous support by long-term mechanical circulatory support (MCS), not including temporary mechanical circulatory support.

Age

  • Patient less than 18 years of age.

Other

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
The Johns Hopkins Hospital
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BaltimoreUnited StatesUnknown status
University of Maryland Medical Center
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BaltimoreUnited StatesUnknown status
Tufts Medical Center
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BostonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
University of Virginia Medical Center
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
The Lindner Christ Hospital
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CincinnatiUnited StatesUnknown status
The Ohio State University -Wexner Medical Center
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ColumbusUnited StatesUnknown status
University of Miami
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Coral GablesUnited StatesUnknown status
Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
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DallasUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
PennState Health - Milton S. Hershey Medical Center
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HersheyUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
University of Texas Health Sciences Center
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HoustonUnited StatesUnknown status
Saint Vincent Medical Group
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IndianapolisUnited StatesUnknown status
Mayo Clinic- Jacksonville, FL
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JacksonvilleUnited StatesUnknown status
The University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
Saint Vincent Heart Clinic Arkansas
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Little RockUnited StatesUnknown status
University of Louisville Hospital
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LouisvilleUnited StatesUnknown status
Loyola University
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MaywoodUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Columbia University
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New YorkUnited StatesUnknown status
NYU Langone Medical Center
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New YorkUnited StatesUnknown status
Sentara Norfolk General Hospital
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NorfolkUnited StatesUnknown status
Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center)
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Oak LawnUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
AdventHealth
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OrlandoUnited StatesUnknown status
Hospital of the University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh Medical Center UPMC Presbyterian
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PittsburghUnited StatesUnknown status
Providence Saint Vincent Medical Center
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PortlandUnited StatesUnknown status
Virginia Commonwealth University Health System
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RichmondUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
Methodist Hospital San Antonio
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San AntonioUnited StatesUnknown status
University of California San Diego
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San DiegoUnited StatesUnknown status
University of California San Francisco Medical Center
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San FranciscoUnited StatesUnknown status
University of Washington Medical Center
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SeattleUnited StatesUnknown status
Stanford University Hospital
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StanfordUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
University of South Florida Health
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TampaUnited StatesUnknown status
Oklahoma Heart Institute
Coordinator of this site? Confirm its status
TulsaUnited StatesUnknown status
Westchester Medical Center
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ValhallaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.