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
- Diseases
- 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
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| The Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Virginia Medical Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Lindner Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Baylor Research Institute Dallas - Baylor University Medical Center (BUMC) Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| PennState Health - Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Texas Health Sciences Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Saint Vincent Medical Group Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Mayo Clinic- Jacksonville, FL Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| The University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Saint Vincent Heart Clinic Arkansas Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| University of Louisville Hospital Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Loyola University Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Langone Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Sentara Norfolk General Hospital Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center) Coordinator of this site? Confirm its status | Oak Lawn | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| AdventHealth Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Medical Center UPMC Presbyterian Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Virginia Commonwealth University Health System Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Methodist Hospital San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| University of California San Francisco Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Stanford University Hospital Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| University of South Florida Health Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Oklahoma Heart Institute Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Westchester Medical Center Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.