Destination Therapy Post Approval Study

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.

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)