Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials

A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure

Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.

Patients who participated in prior trials will be approached for this PAS as follows:

• Patients who are on continued HeartWare® System support, (original or exchange device)
• Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up

Patients who participated in prior trials who will not be approached to participate in this follow-up study include:

• Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial).

No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.

Inclusion Criteria:

1. The patient has participated in a prior HeartWare trial under IDE G070199.
2. The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
3. The patient has signed informed consent for participation in the study.

Exclusion Criteria:

1. The patient is unwilling or unable to comply with trial requirements.
2. The patient did not sign the informed consent.