Heart Failure Clinical Trial
Destination Therapy Post Approval Study
Summary
Medtronic is sponsoring the HeartWareâ„¢ HVADâ„¢ 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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 45 Locations for this study
Little Rock Arkansas, 72205, United States
San Diego California, 92103, United States
San Francisco California, 94143, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Coral Gables Florida, 33146, United States
Jacksonville Florida, 32224, United States
Orlando Florida, 32804, United States
Tampa Florida, 33606, United States
Chicago Illinois, 60611, United States
Maywood Illinois, 60153, United States
Oak Lawn Illinois, 60453, United States
Indianapolis Indiana, 46260, United States
Kansas City Kansas, 66160, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48202, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
New York New York, 10016, United States
New York New York, 10032, United States
Valhalla New York, 10595, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43210, United States
Tulsa Oklahoma, 74104, United States
Portland Oregon, 97225, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75204, United States
Dallas Texas, 75389, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84132, United States
Charlottesville Virginia, 22908, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98195, United States
Milwaukee Wisconsin, 53226, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.