Clinical trial NCT03681210: Destination Therapy Post Approval Study
Official title: Destination Therapy Post Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Heart Failure
Keywords: Heart Failure
Heart Diseases
Cardiovascular Diseases
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-09-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intended to be implanted with a HVAD for use as a destination therapy are eligible for enrollment into the DT PAS and must be consented for the PAS prior to the HVAD implant. The PAS cohort will be comprised of 300 newly enrolled PAS patients.

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.

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.

Primary outcomes:
measure: Long-term complication free survival
timeFrame: Implant to 2 years
Secondary outcomes:
measure: Rate of stroke
timeFrame: Implant to 2 years
measure: Rate of late stroke
timeFrame: 2 years post-implant to 5 years
measure: Stroke severity
timeFrame: Occurrence of stroke to 24 weeks post-stroke
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Saint Vincent Heart Clinic Arkansas
state: Arkansas
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic (Jacksonville FL)
state: Florida
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Tampa
country: United States
facility: University of South Florida Health
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center)
state: Illinois
city: Indianapolis
country: United States
facility: Saint Vincent Medical Group
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Lindner Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Hershey
country: United States
facility: PennState Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: