ACTRN12615001036505
终止
不适用
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2015年10月6日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Advanced heart failure
- 发起方
- HeartWare Inc.
- 入组人数
- 11
- 状态
- 终止
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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