HeartMate 3 ELEVATE™ Registry

Study Overview
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Brief Summary
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Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.

Detailed Description
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The purpose of this post-market registry is to collect data and evaluate the real-world experience of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) in a post-approval setting.

Official Title
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Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)

Conditions
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Cardiovascular Disease, Heart Failure, Ventricular Dysfunction

Intervention / Treatment
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* Device: HeartMate 3


Participation Criteria
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Eligibility Criteria
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Inclusion: Patient consented to registry data collection Patient has met the HeartMate 3 commercially approved labeling indication and is implanted with the HM3.
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 |
| --- | --- |
| HeartMate 3<br>This registry will include all patients that receive the HM3 LVAS in the post-market setting | Device: HeartMate 3<br>* Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3<br>* Other names: HM3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Patients will be followed in the registry to 24 months post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first. | Up to 24 Months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQoL-5D-5L (EQ-5D-5L) | EQ-5D-5L measures self-rated health states/quality of life in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and extreme problems) | Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS | 
| Six Minute Walk Test (6MWT) | The Six Minute Walk Test (6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status. | Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS | 
| New York Heart Association (NYHA) Classification | NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort | Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS | 
| Adverse Events | Frequency and incidence of pre-defined anticipated adverse event rates | Up to 24 months | 
| Device Malfunctions | Frequency and incidence of device malfunction rates | Up to 24 months | 
| Reoperations | Frequency and incidence of reoperations after initial implant surgery | Up to 24 months | 
| Rehospitalizations | Frequency and incidence of rehospitalizations after initial discharge from implant surgery | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HeartMate 3, LVAS, LVAD, Heart-assist devices, Thoratec Corporation