HeartMate 3 CE Mark Study Long Term Follow-up

Study Overview
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Brief Summary
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The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up. The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.

Official Title
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HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan

Conditions
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Advanced Refractory Left Ventricular Heart Failure

Intervention / Treatment
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* Other: Long term follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or legal representative has signed Informed Consent Form (ICF). Patient was enrolled in the HeartMate 3 CE Mark Study and continues to be supported with the HeartMate 3 LVAS after the 2 year CE Mark study follow-up. Exclusion Criteria: 1. Patient does not consent to the continued data collection.

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 |
| --- | --- |
| Ongoing HM3 CE Mark study patients<br>The study will include the ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection. | Other: Long term follow-up<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Subject outcomes and survival over time | At 5 years post HM3 CE Mark study implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQoL 5D-5L (EQ-5D-5L) VAS Score | Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L) VAS Score. The Visual Analog Scale (VAS) records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life | At 5 years post HM3 CE Mark study implant | 
| Six Minute Walk Test (6MWT) | Functional status over time as measured by the Six Minute Walk Test (6MWT). The 6MWT is done to establish the amount of meters a subject can walk in 6 minutes | At 5 years post HM3 CE Mark study implant | 
| New York Heart Association (NYHA) | Functional status over time as measured by New York Heart Association (NYHA). Patients are graded from 4 to 1 in order or symptoms: I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). IIIA Marked limitation of physical activity. No dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IIIB Marked limitation of physical activity. Recent dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | At 5 years post HM3 CE Mark study implant | 
| Adverse Events | Number of Participants with Adverse Events | Between 2 and 5 years post HM3 CE Mark study implant | 
| Device Malfunctions | Number of Participants with device malfunctions | Between 2 and 5 years post HM3 CE Mark study implant | 
| Reoperations | Number of reoperations | Between 2 and 5 years post HM3 CE Mark study implant | 
| Rehospitalizations | Number of rehospitalizations | Between 2 and 5 years post HM3 CE Mark study implant | 
| Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3) | Modified Rankin Score >3 is considered debilitating. As in 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed. The MRS scale is as following: 0: No observed neurological symptoms; 1: No significant neurological disability despite symptoms; able to carry out all usual duties and activities; 2: Slight neurological disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate neurological disability; requiring some help, but able to walk without assistance; 4: Moderate severe neurological disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe neurological disability; bedridden, incontinent and requiring constant nursing care and attention as a result of a neurological deficit; 6: Dead | As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Disease, Cardiovascular Disease, Heart-assist Devices, Thoratec Corporation