for people ages 19 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:



This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database. All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.

Official Title

A Prospective, Single-Arm, Multi-Center Study in Collaboration With the Intermacs to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure


Left Sided Heart Failure Heart Failure HeartWare HVAD Thoracotomy HeartWare HVAD via Thoracotomy


You can join if…

Open to people ages 19 years and up

  1. Must be ≥19 years of age at time of informed consent to participate in the Intermacs®registry.
  2. Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).
  3. Subject signed an Intermacs® informed consent if required by local IRB policy.
  4. Subject signed a HeartWare informed consent.

You CAN'T join if...

  1. Subject is incarcerated (prisoner).
  2. Subject did not sign the informed consent at sites where waiver of consent was not granted.
  3. Body Surface Area (BSA) < 1.2 m2.

  4. Prior cardiac transplant or cardiomyoplasty.
  5. Subject is receiving a BiVAD.
  6. Subject is receiving the device as an RVAD.
  7. Subject data is generated from non- Intermacs® centers.
  8. Pediatric subjects (< 19 years of age).
  9. Subjects who receive a temporary LVAD
  10. . Subjects whose device strategy is listed as "Destination Therapy" at the time of implant.
  11. . Severe Right Heart failure
  12. . Aortic insufficiency or mechanical aortic valve.
  13. . Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair).
  14. . Known LV Thrombus.


  • UC San Diego
    San Diego California 92093 United States
  • Stanford University School of Medicine
    Palo Alto California 94305 United States
  • UCSF Medical Center
    San Francisco California 94143 United States
  • University of Washington Medical Center
    Seattle Washington 98195-6310 United States
  • St. Paul's Hospital
    Vancouver British Columbia Canada
  • St. Luke's Hospital of Kansas City
    Kansas City Missouri 64111 United States


in progress, not accepting new patients
Start Date
Completion Date
Medtronic Cardiac Rhythm and Heart Failure
Study Type
Last Updated
May 24, 2018