Destination Therapy Post Approval Study (NCT03681210)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (6 items).
Location: Saint Vincent Heart Clinic Arkansas — Little Rock, Arkansas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
- Patient less than 18 years of age.
- Patient with previous support by long-term mechanical circulatory support (MCS), not including temporary mechanical circulatory support.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (47 Sites)
- Saint Vincent Heart Clinic Arkansas — Little Rock, Arkansas
- University of California San Diego — San Diego, California
- University of California San Francisco Medical Center — San Francisco, California
- Stanford University Hospital — Stanford, California
- University of Colorado — Aurora, Colorado
- University of Miami — Coral Gables, Florida
- Mayo Clinic (Jacksonville FL) — Jacksonville, Florida
- AdventHealth — Orlando, Florida
- University of South Florida Health — Tampa, Florida
- Northwestern University — Chicago, Illinois
- Loyola University — Maywood, Illinois
- Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center) — Oak Lawn, Illinois
- Saint Vincent Medical Group — Indianapolis, Indiana
- The University of Kansas Medical Center — Kansas City, Kansas
- University of Louisville Hospital — Louisville, Kentucky
- University of Maryland Medical Center — Baltimore, Maryland
- The Johns Hopkins Hospital — Baltimore, Maryland
- Tufts Medical Center — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Henry Ford Health System — Detroit, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Mayo Clinic Rochester — Rochester, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- University of Nebraska Medical Center — Omaha, Nebraska
- NYU Langone Medical Center — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.