Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS

Study Overview
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Brief Summary
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This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS). The objective of this study is to evaluate the implantation of the HM3 utilizing techniques other than full median sternotomy (e.g. thoracotomy) and impact on post-implant length of stay.

Official Title
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Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy

Conditions
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Advanced Refractory Left Ventricular Heart Failure

Intervention / Treatment
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* Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject or Legal Representative has provided written informed consent by signing the study Informed Consent Form (ICF) Subject must be ≥ 18 years of age at the time of informed consent Subject is receiving the HM3 as their first LVAD Body surface area (BSA) ≥ 1.2m2 Subject is NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV LVEF ≤ 25% Subject is: Inotrope dependent OR Has CI<2.2 L/min/m2, while not on inotropes and meets one of the following criteria: On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond to therapy Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days Females of child bearing age must agree to use adequate contraception Exclusion Criteria Subject has a planned concomitant procedure at time of implant (e.g. valve repair, CABG, ASD repair, etc) Subject has greater than mild aortic insufficiency Physiologically significant (i.e. requires intervention) atrial septal defect Subject has severe right heart failure (RHF) (refer to Appendix 2 for guidance) Subject has planned Bi-VAD support prior to enrollment Presence of mechanical aortic valve that will not be either converted to bioprosthesis or oversewn at the time of LVAD implant Subject has ongoing mechanical circulatory support (MCS) at the time of LVAD surgery other than IABP Subject has a history of any organ transplant Positive pregnancy test Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator Platelet count < 100,000 x 103/L (< 100,000/ml) Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management History of confirmed, untreated AAA > 5 cm in diameter within 6 months of enrollment Presence of an active, uncontrolled infection Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the subjects' health status Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: An INR ≥ 2.0 not due to anticoagulation therapy Total bilirubin > 43 μmol/L (2.5 mg/dl) or biopsy-proven liver cirrhosis History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted Fixed pulmonary hypertension with most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis Serum creatinine ≥ 221 μmol/L (2.5 mg/dl) or the need for chronic renal replacement therapy Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration Pre-albumin < 150mg/liter (15 mg/dl) or albumin <30 g/liter (3g/dl) (if only one available); pre-albumin <150mg/liter (15 mg/dl) and albumin <30 g/liter (3 g/dl) (if both available) Subject has known hypo- or hyper-coagulable states such as disseminated intravascular coagulation and heparin-induced thrombocytopenia Participation in any other clinical investigation that is likely to confound study results or affect the study

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 |
| --- | --- |
| Treatment Arm<br>The treatment arm will have the HM3 LVAS implanted utilizing a technique other than full median sternotomy (e.g. thoracotomy). | Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS)<br>* This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients surviving at 6 months free of debilitating stroke (Modified Rankin Score > 3), device malfunction requiring re-operation to replace or remove the device, or conversion of the implant surgical approach to open sternotomy. | The composite primary endpoint of the study is survival at 6 months free of debilitating stroke (Modified Rankin Score > 3), device malfunction requiring re-operation to replace or remove the device, or conversion of the implant surgical approach to open sternotomy. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Mean length of hospital stay from implant to hospital discharge | Initial hospital stay, approximately 3 weeks |