Destination Therapy Post Approval Study
- Conditions
- Chronic Heart Failure
- 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
- 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)
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
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