A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 451
- 试验地点
- 95
- 主要终点
- Stroke-Free Survival Probability for 2 Years Post Implant
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/ New York Heart Association (NYHA) Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.
详细描述
The HeartWare Ventricular Assist System (VAS) is intended for use in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy and who are ineligible for cardiac transplantation. The ENDURANCE clinical study is a prospective, randomized, unblinded, multi-center, non-inferiority evaluation of the HeartWare® VAS versus a control group consisting of any FDA-approved Left Ventricular Assist Device (LVAD) approved for destination therapy. Patients are randomized to HeartWare® VAS or control LVAD in a 2:1 ratio. Each patient receiving the HeartWare® VAS or control LVAD is followed to the primary endpoint at 2 years, with a subsequent follow-up period extending to 5 years post implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be ≥18 years of age at consent
- •Body Surface Area (BSA) ≥ 1.2 m2
- •Patients with advanced heart failure symptoms (New York Heart Association (NYHA) Class IIIB or IV) who are: (patient must meet one of the following) 3a. 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 3b. In NYHA Class III or NYHA 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 either the HeartWare® VAS or control LVAD
- •Female patients of childbearing potential must agree to use adequate contraceptive precautions for the duration of the study.
- •The patient or legally authorized representative has signed the informed consent form
排除标准
- •Body Mass Index (BMI) > 40
- •Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
- •Prior cardiac transplant.
- •History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm.
- •Cardiothoracic surgery within 30 days of randomization.
- •Acute myocardial infarction within 14 days of implant
- •Patients eligible for cardiac transplantation
- •On ventilator support for > 72 hours within the four days immediately prior to randomization and implant.
- •Pulmonary embolus within three weeks of randomization
- •Symptomatic cerebrovascular disease, stroke within 180 days of randomization or > 80% stenosis of carotid or cranial vessels.
- •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) or right atrial pressure > 20 mmHg on multiple inotropes, right ventricular ejection fraction (RVEF) <15% or clinical signs
- •Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing.
- •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 randomization or requiring dialysis (does not include use of ultra-filtration for fluid removal).
- •Specific liver enzymes [AST (SGOT) and ALT (SGPT)] > 3 times upper limit of normal within 72 hours of randomization.
- •A total bilirubin > 3 mg/dl within 72 hours of randomization, or biopsy proven liver cirrhosis or portal hypertension.
- •Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation and the PVR > 6 Wood units.
- •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 Chronic Obstructive Pulmonary Disease (COPD) or severe restrictive lung disease
- •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
- •Patient unwilling or unable to comply with study requirements
- •Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
研究组 & 干预措施
HeartWare® VAS
Implant of HeartWare® Ventricular Assist System
干预措施: HeartWare® VAS (Device)
Control LVAD
Implant of FDA-approved LVADs approved for destination therapy
干预措施: Control LVAD (Device)
结局指标
主要结局
Stroke-Free Survival Probability for 2 Years Post Implant
时间窗: Implant to 2 years
The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, electively transplanted or explanted due to patient recovery and free from disabling stroke (Modified Rankin Scale \>=4). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability. Weibull model estimates of survival probability (shown as a percent of 100) are used.
次要结局
- Change in Functional Status Measured by New York Heart Association (NYHA) Class(Change from baseline to 2 years)
- Length of Initial Hospitalization(Implant to the end of the initial hospitalization)
- Duration of Re-hospitalization(Implant to two years)
- Overall Survival at 2 Years(Implant to two years)
- Change in Functional Status as Measured by 6-minute Walk(Change from baseline to 2 years)
- Number of Participants With Bleeding(Implant to two years)
- Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)(Change from baseline to 2 years)
- Number of Participants Who Had a Re-hospitalization(Implant to two years)
- Cause of Re-hospitalization(Implant to two years)
- Number of Participants With Major Infections(Implant to two years)
- Number of Participants With Device Malfunctions(Implant to two years)
- Health Status Change Measured by EuroQol EQ-5D (Version 3L)(Change from baseline to 2 years)