Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials (HW-PAS-03)

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: HeartWare® VAS

Study type: Observational

Funder types: Industry

Identifiers

NCT01832610

HW-PAS-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

101 participants in 1 patient group

HeartWare® VAS

Description:

Ventricular Assist Device (HeartWare® VAS)

Treatment:

Device: HeartWare® VAS