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DT PAS: Destination Therapy Post Approval Study

Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03681210
Collaborator
(none)
300
Enrollment
47
Locations
89
Anticipated Duration (Months)
6.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HeartWare Ventricular Assist Device

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Destination Therapy Post Approval Study
Actual Study Start Date :
Oct 31, 2018
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Patients implanted with HVAD System

Patients intended to be implanted with a HVAD for use as destination therapy are eligible for enrollment into the DT PAS and must be consented for the study prior to the HVAD implant.

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).
Other Names:
  • HVAD

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Long-term complication free survival [Implant to 2 years]

      Complications include death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation.

    Secondary Outcome Measures

    1. Rate of stroke [Implant to 2 years]

      The rate of stroke on device will be analyzed using Kaplan-Meier methods.

    2. Rate of late stroke [2 years post-implant to 5 years]

      The rate of late stroke on device will be analyzed using Kaplan-Meier methods for those surviving stroke-free for 24 months post-implant.

    3. Stroke severity [Occurrence of stroke to 24 weeks post-stroke]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Vincent Heart Clinic Arkansas Little Rock Arkansas United States 72205
    2 University of California San Diego San Diego California United States 92103
    3 University of California San Francisco Medical Center San Francisco California United States 94143
    4 Stanford University Hospital Stanford California United States 94305-5330
    5 University of Colorado Aurora Colorado United States 80045
    6 University of Miami Coral Gables Florida United States 33146
    7 Mayo Clinic (Jacksonville FL) Jacksonville Florida United States 32224
    8 AdventHealth Orlando Florida United States 32804
    9 University of South Florida Health Tampa Florida United States 33606
    10 Northwestern University Chicago Illinois United States 60611-2969
    11 Loyola University Maywood Illinois United States 60153
    12 Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center) Oak Lawn Illinois United States 60453
    13 Saint Vincent Medical Group Indianapolis Indiana United States 46260
    14 The University of Kansas Medical Center Kansas City Kansas United States 66160
    15 University of Louisville Hospital Louisville Kentucky United States 40202
    16 University of Maryland Medical Center Baltimore Maryland United States 21201
    17 The Johns Hopkins Hospital Baltimore Maryland United States 21287
    18 Tufts Medical Center Boston Massachusetts United States 02111
    19 Massachusetts General Hospital Boston Massachusetts United States 02114
    20 Henry Ford Health System Detroit Michigan United States 48202
    21 University of Minnesota Minneapolis Minnesota United States 55455
    22 Mayo Clinic Rochester Rochester Minnesota United States 55905
    23 Washington University School of Medicine Saint Louis Missouri United States 63110
    24 University of Nebraska Medical Center Omaha Nebraska United States 68198
    25 NYU Langone Medical Center New York New York United States 10016
    26 Columbia University New York New York United States 10032
    27 Westchester Medical Center Valhalla New York United States 10595
    28 The Lindner Christ Hospital Cincinnati Ohio United States 45219-2906
    29 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210-1240
    30 Oklahoma Heart Institute Tulsa Oklahoma United States 74104
    31 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    32 PennState Health Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    33 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    34 University of Pittsburgh Medical Center UPMC Presbyterian Pittsburgh Pennsylvania United States 15213
    35 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    36 Baylor Research Institute Dallas - Baylor University Medical Center (BUMC) Dallas Texas United States 75204
    37 University of Texas Southwestern Medical Center Dallas Texas United States 75389
    38 Baylor College of Medicine Houston Texas United States 77030
    39 Houston Methodist Hospital Houston Texas United States 77030
    40 University of Texas Health Sciences Center Houston Texas United States 77030
    41 Methodist Hospital San Antonio San Antonio Texas United States 78229
    42 University of Utah Salt Lake City Utah United States 84132
    43 University of Virginia Medical Center Charlottesville Virginia United States 22908
    44 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
    45 Virginia Commonwealth University Health System Richmond Virginia United States 23298
    46 University of Washington Medical Center Seattle Washington United States 98195
    47 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Medtronic Cardiac Rhythm and Heart Failure

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Cardiac Rhythm and Heart Failure
    ClinicalTrials.gov Identifier:
    NCT03681210
    Other Study ID Numbers:
    • DT PAS
    First Posted:
    Sep 24, 2018
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Medtronic Cardiac Rhythm and Heart Failure
    Heart Failure
    Heart Diseases
    Cardiovascular Diseases
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jun 21, 2022