MDT-1118 Japan DT Study

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the MDT-1118 VAD in a patient population for destination therapy (long term support) of advanced heart failure. The collected data will be used to support Japan regulatory application in expanding market approval for destination therapy.

Official Title
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A Prospective, Multi-Center, Single Arm Clinical Study to Evaluate the MDT-1118 Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Ventricular Assist Device System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be ≥20 years of age at consent In judgment of body size, body surface area (BSA) and anatomy by Investigator, patient can be implanted MDT-1118 VAD. Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following) On optimal medical management, including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or In Class III or Class IV heart failure for at least 14 days, and dependent on intra-aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days Left ventricular ejection fraction ≤ 25% LVAD implant is intended as destination therapy Must be able to receive the MDT-1118 VAD Female patients of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study The patient has signed the informed consent form and advance directive The patient and the family understand that destination therapy is end-of-life medical care. Exclusion Criteria: Patients with INTERMACS profile 1 Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) Prior cardiac transplant History of confirmed, untreated abdominal/ thoracic aortic aneurysm > 5 cm, or cardiac aneurysm or intraventricular septum rupture Severe calcification in thoracic aorta Cardiothoracic surgery within 14 days of implantation Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities as described in the guidelines published in ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction1 Patients eligible for cardiac transplantation On ventilator support for > 72 hours within the four days immediately prior to implantation Pulmonary embolus within 21 days of implantation as documented by computed tomography (CT) scan or magnetic resonance imaging (MRI) Symptomatic cerebrovascular disease, stroke within 180 days of implantation or > 80% stenosis of carotid or cranial vessels Patient seems difficult to control device by oneself due to cerebral disorder History of drug intoxication or alcohol dependence Uncorrected moderate to severe aortic insufficiency. Correction may include repair or bioprosthesis at the time of implant Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO) at the time of screening or right atrial pressure > 20 mmHg on multiple inotropes or right ventricular ejection fraction (RVEF) <15% with clinical signs of severe right heart failure (e.g. Lower extremity edema, ascites or pleural effusions refractory to treatment with diuretics and two inotropic drugs) Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, INR > 2.0 or PTT > 2.5 times control in the absence of anticoagulation therapy) Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status Serum creatinine > 3.0 mg/dL within 72 hours of implantation or requiring dialysis or ultrafiltration Specific liver enzymes [AST (SGOT) and ALT (SGPT] > 3 times upper limit of normal within 72 hours of implantation A total bilirubin > 3 mg/dL within 72 hours of implantation, or biopsy proven liver cirrhosis or portal hypertension Patients with a mechanical heart valve Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy History of severe COPD or severe restrictive lung disease (e.g FEV1 <50%) or severe pulmonary hypertension Participation in any other study involving investigational drugs or devices Severe illness, other than heart disease, which would limit survival to < 3 years Peripheral vascular disease with rest pain or ischemic ulcers of the extremities Pregnancy Patient unwilling or unable to comply with study requirements Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator Inadequate family/social support Systemic disease including collagen disease, insulin dependent severe diabetes or irreversible multi-organ failure.

Ages Eligible for Study
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Minimum Age: 20 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ventricular Assist Device System|Ventricular Assist Device System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success at 12 months with the following definitions of success and failure | Therapy will be considered a success if, at the end of 12 months in the study: The subject is alive; and The subject has not had a stroke of Modified Rankin Score ≥ 4; and The subject retains the originally implanted device, unless the device was removed due to heart recovery, or the patient is electively transplanted. Therapy will be considered a failure if, within the 12 months in the study: The subject dies; or The subject has a stroke of Modified Rankin Score ≥ 4; or The device malfunctions or fails, requiring exchange, explantation, or urgent transplantation. | Implant to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all adverse events per INTERMACS definition |  | Implant to 12 months | 
| Incidence of all device malfunctions per INTERMACS definition |  | Implant to 12 months | 
| Health Status improvement, as measured by KCCQ |  | Implant to 12 months | 
| Health Status improvement, as measured by EuroQol EQ-5D-5L |  | Implant to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Heart Failure, Ventricular Assist Device System, Destination Therapy