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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 101
- Locations
- 25
- Primary Endpoint
- Overall Survival on Device
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient has participated in a prior HeartWare trial under IDE G
- •The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
- •The patient has signed informed consent for participation in the study.
Exclusion Criteria
- •The patient is unwilling or unable to comply with trial requirements.
- •The patient did not sign the informed consent.
Outcomes
Primary Outcomes
Overall Survival on Device
Time Frame: Implant to 5 years
Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.
Secondary Outcomes
- Change in Functional Status Measured by 6-minute Walk(Change from baseline to 5 years)
- Final Patient Status(Implant to 5 years)
- Number of Participants Experiencing Any Adverse Event Per Intermacs Definition(Enrollment into HW-PAS-03 to 5 years)
- Health Status Change Measured by EuroQol EQ-5D (Version 5L)(Enrollment to 5 years)
- Re-hospitalizations(Enrollment into HW-PAS-03 to 5 years)
- Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)(Change from baseline to 5 years)
- Change in Functional Status Measured by New York Heart Association (NYHA) Class(Change from baseline to 5 years)