MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS

Study Overview
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Brief Summary
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The study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the MOMENTUM 3 IDE trial. A total of 1028 subjects were enrolled in the MOMENTUM 3 IDE trial. Approximately 533 subjects were ongoing support at the 2-year follow-up and are eligible for enrollment in this PAS. This study will be conducted at sites that participated in the MOMENTUM 3 IDE trial which will include up to 69 centers in the United States.

Detailed Description
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Subjects on LVAD support after the MOMENTUM 3 IDE trial 2-year follow-up visit can be enrolled after providing consent to extended follow-up. They will be followed to 5 years post-implant or outcome (transplant, explant or death), whichever occurs first. Subjects who have been transplanted, their device exchanged to another pump other than a HM II or HM3, or explanted after the MOMENTUM 3 IDE trial 2-year follow-up but prior to providing consent for this PAS can also be enrolled. Data between the 2-year follow-up visit and the date of pump exchange, explant, or transplant will be retrospectively collected. Once enrolled, if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed. In the event that a subject expired prior to providing consent, IRB approval will be obtained to collect the date and cause of death.

Official Title
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MOMENTUM 3 Pivotal Cohort Extended Follow-up Post-Approval Study

Conditions
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Advanced Refractory Left Ventricular Heart Failure

Intervention / Treatment
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* Device: HM3 LVAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject or legal representative has signed Informed Consent Form (ICF) Subject was enrolled in the MOMENTUM 3 IDE trial and was ongoing at the 2-year follow-up visit Exclusion Criteria: Subject or legal representative does not consent to extended data collection after the MOMENTUM 3 IDE trial 2-year follow-up visit Special Circumstance: Sites with patients who expired after the MOMENTUM 3 IDE trial 2-year follow-up visit but prior to signing the ICF for this PAS will obtain IRB approval to collect only the date and cause of death
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

| Intervention/Treatment |
| --- |
|Device: HM3 LVAS|HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump | up to 5 years post-implant | 
| Subject outcomes and survival | Subject outcomes and survival which includes death, transplant, explant, or a pump exchange to any device other than HM II or HM3 | up to 5 years post-implant | 
| Bleeding (including GI bleeding) | Frequency and incidence of bleeding (including GI bleeding) | up to 5 years post-implant | 
| Major infection | Frequency and incidence of major infection | up to 5 years post-implant | 
| Hemolysis | Frequency and incidence of hemolysis | up to 5 years post-implant | 
| Device thrombosis | Frequency and incidence of device thrombosis | up to 5 years post-implant | 
| Neurological dysfunction | Frequency and incidence of neurological dysfunction | up to 5 years post-implant | 
| Device related SAEs | Frequency and incidence of device related SAEs | up to 5 years post-implant | 
| NYHA | New York Heart Association (NYHA) classification | up to 5 years post-implant | 
| 6MWD | Six-minute walk distance (6MWD) | up to 5 years post-implant |