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

Study ID
STU 122012-029

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Sangita Sethuram
214-645-7728
sangita.sethuram@utsouthwestern.edu

Principal Investigator
Dan Meyer

Summary

no new patiens are being screened or implanted with the HeartWare System for this trial, as it is a follow-up study only. all patients will have an enrollment visit and then be followed at 6 month intervals until 5 years post implant of the original HeartWare device. Patients who are explanted for transplant or recovery will be followed to 6 months post explant at which point their participation in the trial will be considered complete. This visit will record patient status only.

Participant Eligibility

1. The patient has participated in a prior HeartWare trial under IDE G070199 (UTSW IRB study00000021)
2. The patient was implanted with the HeartWare(RegisteredTM) Ventricular Assist System and was an active patient in the prior trial.
3. The patient has signed informed consent for participation in the study.