HeartMate 3™ LIS Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.

Detailed Description
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This study will evaluate the less invasive implantation technique of the HM 3 LVAS.

Official Title
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Thoratec Corporation HeartMate 3™ Less Invasive Surgery (LIS) Study

Conditions
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Heart Failure, Cardiovascular Disease

Intervention / Treatment
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* Procedure: Less Invasive Surgery (LIS)
* Device: HeartMate 3™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or legal representative has signed Informed Consent Form (ICF) Age ≥ 18 years BSA ≥ 1.2 m2 NYHA IIIB or IV, or ACC/AHA Stage D LVEF ≤ 25% CI ≤ 2.2 L/min/m2, while not on inotropes (if Patient is treated with inotropes at baseline, this does not apply) Patients must also meet one of the following: On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond, OR In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on intraaortic balloon pump (IABP) for at least 7 days, OR Inotrope dependent/unable to wean from inotropes OR Listed for transplant Females of child bearing age must agree to use adequate contraception- Exclusion Criteria: 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 Existence of ongoing mechanical circulatory support (MCS) other than IABP Positive pregnancy test if of childbearing potential Lactating mothers Presence of mechanical aortic cardiac valve History of any organ transplant 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 Presence of an active, uncontrolled infection Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the Investigator will require based upon the patients' health status Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: An INR ≥ 2.5 not due to anticoagulation therapy Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 <50% predicted Fixed pulmonary hypertension with a 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%) carotid artery stenosis Serum Creatinine ≥ 221umol/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 Aortic valve regurgitation > grade 1 Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL) Planned Bi-VAD support prior to enrollment Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia Planned concomitant intra-cardiac cardiac surgery Thrombus formation in the atrium or left ventricle identified by echocardiogram Previous sternotomy or left-sided thoracotomy Participation in any other clinical investigation that is likely to confound study results or affect the study Any condition other than HF that could limit survival to less than 6 months

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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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HM 3 LIS<br>All patients implanted with the HM 3 LVAD via less invasive surgical technique | Procedure: Less Invasive Surgery (LIS)<br>* Less invasive HM 3 LVAD surgical implant procedure<br>Device: HeartMate 3™<br>* HM 3 LIS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of survival participants |  | 30 days | 

 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, Advanced, Ventricular Dysfunction, refractory left ventricular, Thoratec Corporation