Overview

This trial is active, not recruiting.

Condition heart failure
Treatment hvad® system
Sponsor HeartWare, Inc.
Start date January 2013
End date October 2017
Trial size 115 participants
Trial identifier NCT01832610, HW-PAS-03

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Arm
hvad® system

Primary Outcomes

Measure
Survival
time frame: 5 years post implant
Patient Status
time frame: 5 years post implant
Re-hospitalizations
time frame: 5 years post implant
Incidence of Adverse Events
time frame: 5 years post implant
Quality of Life measures
time frame: 5 years post implant
Functional Status
time frame: 5 years post implant
Observational
time frame: 5 years post implant

Secondary Outcomes

Measure
Overall survival
time frame: 5 years post implant

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by HeartWare, Inc..