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Eligibility
for people ages 19 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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 will be current INTERMACS® sites in good standing and will follow the INTERMACS® protocol and procedures.

Official Title

A Prospective, Single Arm, Multi-Center Clinical Study in Collaboration With the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) to Evaluate the Thoracotomy Implant Technique of the HeartWare HVAD® System in Patients With Advanced Heart Failure (HVAD LATERAL)

Keywords

Left Sided Heart Failure

Eligibility

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 m^2.
  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.

Locations

  • Stanford University School of Medicine
    Palo Alto, California, 94305, United States
  • Cedars Sinai Medical Center
    Los Angeles, California, 90048, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
HeartWare, Inc.
ID
NCT02268942
Lead Scientist
Georg Wieselthaler
Study Type
Interventional
Last Updated
February 1, 2017