atients 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.