Evaluation of the Heartware Ventricular Assist System for the Treatment of Advanced Heart Failure- Continued Access Protocol Amendment

Study ID
Study00000021

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul

Contact
Mary Weyant
214-645-7728
mary.weyant@utsouthwestern.edu

Principal Investigator
Dan Meyer

Summary

This is a multi-center, prospective trial. Each patient is followed to death, device explant, or cardiac transplantation, whichever occurs first.

After the surgical recovery period, patients are allowed to leave the hospital if they have met additional criteria for off-site excursions and hospital discharge. Patient outcomes and adverse events will be reported to the FDA as supplemental information to IDE G070199.

Participant Eligibility

1.Must be at least 18 years of age at enrollment.
2. Body Surface Area (BSA) greater than or equal to 1.2 m2.
3. Patient is NYHA Class IV
4. Patient listed for cardiac transplantation
5. Patient meets United Network for Organ Sharing (UNOS) Status 1A or 1B
listing criteria.
6. HeartWare® LVAD implant is planned as a bridge to transplant
7. Must be approved to receive the HeartWare® VAS
8. The patient or legally authorized representative has signed the informed
consent form