A Study to Evaluate the Thoracotomy Implant Technique of the HeartWare HVAD System in Patients with Advanced Heart Failure

Overview

About this study

This is a prospective, multi-center,single arm study that will evaluate the thoracotomy implant technique in up to 120 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 will be current INTERMACS® sites in good standing and will follow the INTERMACS® protocol and procedures.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

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

 

Exclusion Criteria

  • Subject is incarcerated (prisoner)
  • Subject did not sign the informed consent at sites where waiver of consent was not granted
  • Body Surface Area (BSA) < 1.2 m^2
  • Prior cardiac transplant or cardiomyoplasty
  • Subject is receiving a BiVAD
  • Subject is receiving the device as an RVAD
  • Subject data is generated from non- INTERMACS® centers
  • Pediatric subjects (< 19 years of age)
  • Subjects who receive a temporary LVAD
  • Subjects whose device strategy is listed as "Destination Therapy" at the time of implant
  • Severe Right Heart failure
  • Aortic insufficiency or mechanical aortic valve
  • Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair)
  • Known LV Thrombus

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

John Stulak, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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