The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 93
- 主要终点
- Composite Endpoint
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.
The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
详细描述
The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver.
The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.
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
- •The following are general criteria; more specific conditions are included in the study protocol:
- •Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
- •On optimal medical management and are failing to respond; or
- •In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
- •Treated with ACE inhibitors or beta-blockers and found to be intolerant.
- •Ineligible for cardiac transplant
- •VO2max <=14 ml/kg/min
- •LVEF <=25%
排除标准
- •The following are general criteria; more specific conditions are included in the study protocol:
- •Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
- •Existence of factors that would adversely affect patient survival or function of the LVAS
- •Intolerance to anticoagulant or antiplatelet therapies.
- •Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
- •Participation in any other clinical investigation that is likely to confound study results or affect study outcome
结局指标
主要结局
Composite Endpoint
时间窗: Patients' status at 2 years post-implant
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
次要结局
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline, Months 1, 3, 6, 12)
- Six Minute Walk Test (6MWT)(Baseline, Months 1, 3, 6, 12)
- Functional Status (Patient Activity Score)(Baseline, Months 1, 3, 6, 12)
- Reoperations(Patients were followed until outcome or up to 2 years post-implant, whichever came first)
- Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Trail Making B(Baseline (1 month), 6 months)
- Minnesota Living With Heart Failure Questionnaire(MLWHF)(Baseline, Months 1,3,6,12)
- New York Heart Association (NYHA) Classification(Baseline, Months 1, 6, 12)
- Neurocognitive Assessments, Clock Drawing(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Trail Making A(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Boston Naming Test(Baseline (1 month), 6 months)