Destination Therapy Post Approval Study

Chronic Heart Failure Clinical Trial

— DT PAS  

Official title:

Destination Therapy Post Approval Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03681210
• Other study ID #: DT PAS
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

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