Multi center, prospective, non-randomized, single-arm clinical trial evaluating the clinical safety and performance of the HeartWare MVAD 'Registered Trademark' system for the treatment of advanced heart failure (MVAD-Advantage Trial)

HeartWare Inc.0 个研究点目标入组 11 人开始时间: 2015年10月6日最近更新: 2020年1月13日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方
入组人数: 11

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Non-randomised trial
主要目的: Treatment

入排标准

年龄范围: 18 Years 至 o limit（—）
性别: All

入选标准

•1.Must be greater than or equal to18 years of age at consent
•2.Subjects with advanced heart failure symptoms (Class IIIB or IV) who meet one of the following):
•a. 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
•b. in Class III or Class IV heart failure for at least 14 days and dependent on intra-aortic balloon pump (IABP) and/or inotropes.
•3.Left ventricular ejection fraction less than or equal to 25%.
•4.Female subjects 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.
•5.The subject has signed the informed consent form.

排除标准

•1.Body Mass Index (BMI) > 47.
•2.Body Surface Area (BSA) < 1.0 m2.
•3.Partial or full mechanical circulatory support within thirty days of implant.
•4.Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA 'Registered Trademark'.
•5.Prior cardiac transplant or cardiomyoplasty.
•6.History of confirmed, untreated abdominal or thoracic aortic aneurysm (diameter > 5 cm).
•7.Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the electrocardiogram (ECG), diagnostic biomarkers, ongoing pain and hemodynamic abnormalities.
•8.On ventilator support for > 72 hours within the four days immediately prior to implant.
•9.Pulmonary embolus within three weeks of implant as documented by computed tomography (CT) scan or nuclear scan.
•10.Symptomatic cerebrovascular disease, stroke within 180 days of implant or > 80% stenosis of carotid or cranial vessels in the absence of confirmed collateral circulation
•11.Uncorrected moderate to severe aortic insufficiency.
•12.Severe right ventricular failure as defined by the anticipated need for extracorporeal membrane oxygenation (ECMO) at the time of screening.
•13.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.
•14.Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, International Normalized Ratio (INR) > 2.0 or Partial Thromboplastin Time (PTT) > 2.5 times control in the absence of anticoagulation therapy).
•15.Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the subject’s health status.
•16.Serum creatinine > 3.0 mg/dL within 72 hours of implant or requiring dialysis.
•17.Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT)] > 3 times upper limit of normal within 72 hours of implant.
•18.A total bilirubin > 3 mg/dL within 72 hours of implant, or biopsy proven liver cirrhosis or portal hypertension.
•19.Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation.
•20.Subjects with a mechanical heart valve.
•21.Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
•22.History of severe COPD or severe restrictive lung disease (e.g. FEV1 < 50% predicted value).
•23.Participation in any other trial involving investigational drugs or devices within 4 weeks prior to screening and last visit of the trial.
•24.Severe illness, other than heart disease, which would limit survival to < 3 years.
•25.Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
•26.Pregnancy and breast feeding.
•27.Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the CIP and LVAD.
•28.Subject unwilling or unable to comply with trial requirements.
•29.Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.

研究者

发起方

HeartWare Inc.

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