Destination Therapy Post Approval Study

Running, not enrolling

Conditions studied: Chronic Heart Failure

In brief

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.

Key facts

Study ID

NCT03681210

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

300

Starts

2018-10-31

Expected to finish

2026-04-01

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Patient less than 18 years of age.
• Patient with previous support by long-term mechanical circulatory support (MCS), not including temporary mechanical circulatory support.

Where it is running

• Saint Vincent Heart Clinic Arkansas — Little Rock, Arkansas, United States
• University of California San Diego — San Diego, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• Stanford University Hospital — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Miami — Coral Gables, Florida, United States
• Mayo Clinic (Jacksonville FL) — Jacksonville, Florida, United States
• AdventHealth — Orlando, Florida, United States
• University of South Florida Health — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Loyola University — Maywood, Illinois, United States
• Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center) — Oak Lawn, Illinois, United States
• Saint Vincent Medical Group — Indianapolis, Indiana, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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