Destination Therapy Post Approval Study
DT PAS
1 other identifier
observational
300
1 country
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
September 24, 2018
CompletedStudy Start
First participant enrolled
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedAugust 22, 2025
July 1, 2025
7.4 years
September 20, 2018
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term complication free survival
Complications include death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation.
Implant to 2 years
Secondary Outcomes (3)
Rate of stroke
Implant to 2 years
Rate of late stroke
2 years post-implant to 5 years
Stroke severity
Occurrence of stroke to 24 weeks post-stroke
Study Arms (1)
Patients implanted with HVAD System
Patients intended to be implanted with a HVAD for use as destination therapy are eligible for enrollment into the DT PAS and must be consented for the study prior to the HVAD implant.
Interventions
The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).
Eligibility Criteria
Patients intended to be implanted with a HVAD for use as a destination therapy are eligible for enrollment into the DT PAS and must be consented for the PAS prior to the HVAD implant. The PAS cohort will be comprised of 300 newly enrolled PAS patients.
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205, United States
University of California San Diego
San Diego, California, 92103, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Stanford University Hospital
Stanford, California, 94305-5330, United States
University of Colorado
Aurora, Colorado, 80045, United States
University of Miami
Coral Gables, Florida, 33146, United States
Mayo Clinic (Jacksonville FL)
Jacksonville, Florida, 32224, United States
AdventHealth
Orlando, Florida, 32804, United States
University of South Florida Health
Tampa, Florida, 33606, United States
Northwestern University
Chicago, Illinois, 60611-2969, United States
Loyola University
Maywood, Illinois, 60153, United States
Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center)
Oak Lawn, Illinois, 60453, United States
Saint Vincent Medical Group
Indianapolis, Indiana, 46260, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
The Lindner Christ Hospital
Cincinnati, Ohio, 45219-2906, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1240, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
PennState Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
Dallas, Texas, 75204, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75389, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Texas Health Sciences Center
Houston, Texas, 77030, United States
Methodist Hospital San Antonio
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University Health System
Richmond, Virginia, 23298, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2018
First Posted
September 24, 2018
Study Start
October 31, 2018
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
August 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share