The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 71
- 主要终点
- Survival
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 a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying.
The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.
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. Patient outcomes will be compared to objective performance criteria based on historical data from other Thoratec implantable ventricular assist devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 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:
- •Listed for cardiac transplantation
- •NYHA Class IV heart failure symptoms
- •On inotropic support, if tolerated
- •Despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic shock
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
Survival
时间窗: 180 days
Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).
次要结局
- Post-transplant Survival(30 days, 1 year)
- Minnesota Living With Heart Failure Questionnaire (MLWHF)(Baseline to 6 months)
- Reoperations(continuous)
- Clinical Reliability (Malfunctions/Failures)(continuous)
- Kansas City Cardiomyopathy Questionaire (KCCQ)(baseline to 6 months)
- New York Heart Association (NYHA) Classification(baseline, 1 month, 3 months, 6 months)
- Six Minute Walk Test (6MWT)(baseline to 6 months)