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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

300

Study ID:

NCT03681210

Recruitment Status:

Active, not recruiting

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There are 45 Locations for this study

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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, 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, 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
Saint 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, United States
The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, 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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

300

Study ID:

NCT03681210

Recruitment Status:

Active, not recruiting

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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