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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03681210
Other study ID # DT PAS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 31, 2018
Est. completion date April 2026

Study information

Verified date May 2023
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
HeartWare Ventricular Assist Device
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).

Locations

Country Name City State
United States University of Colorado Aurora Colorado
United States The Johns Hopkins Hospital Baltimore Maryland
United States University of Maryland Medical Center Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States University of Virginia Medical Center Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States The Lindner Christ Hospital Cincinnati Ohio
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States University of Miami Coral Gables Florida
United States Baylor Research Institute Dallas - Baylor University Medical Center (BUMC) Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States Henry Ford Health System Detroit Michigan
United States PennState Health Milton S. Hershey Medical Center Hershey Pennsylvania
United States Baylor College of Medicine Houston Texas
United States Houston Methodist Hospital Houston Texas
United States University of Texas Health Sciences Center Houston Texas
United States Saint Vincent Medical Group Indianapolis Indiana
United States Mayo Clinic (Jacksonville FL) Jacksonville Florida
United States The University of Kansas Medical Center Kansas City Kansas
United States Saint Vincent Heart Clinic Arkansas Little Rock Arkansas
United States University of Louisville Hospital Louisville Kentucky
United States Loyola University Maywood Illinois
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Vanderbilt University Medical Center Nashville Tennessee
United States Columbia University New York New York
United States NYU Langone Medical Center New York New York
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center) Oak Lawn Illinois
United States University of Nebraska Medical Center Omaha Nebraska
United States AdventHealth Orlando Florida
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center UPMC Presbyterian Pittsburgh Pennsylvania
United States Providence Saint Vincent Medical Center Portland Oregon
United States Virginia Commonwealth University Health System Richmond Virginia
United States Mayo Clinic Rochester Rochester Minnesota
United States Washington University School of Medicine Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States Methodist Hospital San Antonio San Antonio Texas
United States University of California San Diego San Diego California
United States University of California San Francisco Medical Center San Francisco California
United States University of Washington Medical Center Seattle Washington
United States Stanford University Hospital Stanford California
United States University of South Florida Health Tampa Florida
United States Oklahoma Heart Institute Tulsa Oklahoma
United States Westchester Medical Center Valhalla New York

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Rate of stroke The rate of stroke on device will be analyzed using Kaplan-Meier methods. Implant to 2 years
Secondary Rate of late stroke The rate of late stroke on device will be analyzed using Kaplan-Meier methods for those surviving stroke-free for 24 months post-implant. 2 years post-implant to 5 years
Secondary Stroke severity 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. Occurrence of stroke to 24 weeks post-stroke
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