Destination Therapy Post Approval Study
- Conditions
- Chronic Heart Failure
- Interventions
- Device: HeartWare Ventricular Assist Device
- Registration Number
- NCT03681210
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
- Detailed Description
The HeartWare Destination Therapy (DT) Post Approval Study (PAS) is a prospective, observational, multi-site study. Enrollment into the DT PAS will be comprised of newly enrolled, commercial use DT patients with the HeartWare Ventricular Assist Device System (HVAD System). Patients enrolled in DT PAS will be followed for 5 years post-implant or until study closure, patient death, patient exit from the PAS (i.e., withdrawal of consent), or patient has HVAD device removed without replacement (i.e., transplant, recovery) or device is exchanged for non-HVAD. The total estimated study duration is approximately 7 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients implanted with HVAD System HeartWare Ventricular Assist Device 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.
- Primary Outcome Measures
Name Time Method Long-term complication free survival Implant to 2 years Complications include death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation.
- Secondary Outcome Measures
Name Time Method Stroke severity Occurrence of stroke to 24 weeks post-stroke Modified Rankin Scale (mRS) scores will be collected at the time associated with stroke on device and at 12 and 24 weeks post-stroke. The distribution of mRS scores for all strokes occurring in the study will be presented, separating stroke occurring prior to 24 months post-implant and those occurring greater than 24 months post-implant.
Rate of stroke Implant to 2 years The rate of stroke on device will be analyzed using Kaplan-Meier methods.
Rate of late stroke 2 years post-implant to 5 years The rate of late stroke on device will be analyzed using Kaplan-Meier methods for those surviving stroke-free for 24 months post-implant.
Trial Locations
- Locations (47)
PennState Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of California San Diego
🇺🇸San Diego, California, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
Saint Vincent Medical Group
🇺🇸Indianapolis, Indiana, United States
The Lindner Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Methodist Hospital San Antonio
🇺🇸San Antonio, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of Texas Health Sciences Center
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Saint Vincent Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
University of South Florida Health
🇺🇸Tampa, Florida, United States
Stanford University Hospital
🇺🇸Stanford, California, United States
Mayo Clinic (Jacksonville FL)
🇺🇸Jacksonville, Florida, United States
Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center)
🇺🇸Oak Lawn, Illinois, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Loyola University
🇺🇸Maywood, Illinois, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Columbia University
🇺🇸New York, New York, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Providence Saint Vincent Medical Center
🇺🇸Portland, Oregon, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
🇺🇸Dallas, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Miami
🇺🇸Coral Gables, Florida, United States
AdventHealth
🇺🇸Orlando, Florida, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States