Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: HeartWare® VAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has participated in a prior HeartWare trial under IDE G070199. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HeartWare® VAS<br>Ventricular Assist Device (HeartWare® VAS) | Device: HeartWare® VAS<br>* The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.<br>* Other names: HVAD®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival on Device | 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. | Implant to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final Patient Status | The number and percentage of participants with a given outcome (e.g., alive on device, transplant, death, etc.) as of their last follow up or end of study, whichever occurred first. | Implant to 5 years | 
| Re-hospitalizations | A summary of the number of re-hospitalizations per participant from enrollment into HW-PAS-03 throughout their participation in the study. | Enrollment into HW-PAS-03 to 5 years | 
| Number of Participants Experiencing Any Adverse Event Per Intermacs Definition | Number of participants with an Intermacs adverse event, per the Intermacs definitions. An adverse event is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the medical device. | Enrollment into HW-PAS-03 to 5 years | 
| Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement. | Change from baseline to 5 years | 
| Health Status Change Measured by EuroQol EQ-5D (Version 5L) | The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worse imaginable health state) to 100 (best imaginable health state). | Enrollment to 5 years | 
| Change in Functional Status Measured by New York Heart Association (NYHA) Class | Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III). | Change from baseline to 5 years | 
| Change in Functional Status Measured by 6-minute Walk | Change in functional status, as measured by 6-minute walk test. A positive change in score from baseline indicates an improvement. | Change from baseline to 5 years |