Heartware DT Supplement Study

Investigator: Brian Bruckner, MD

Study Coordinator: Deborah Barr

Status: Enrolling

ClinicalTrials.gov Number: NCT01966458

Phone: 713.441.3916

IRB Number: Pro00009841

Description

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.
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