Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 50
- 主要终点
- Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
研究概览
简要总结
Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation.
Study Population The patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. Patients must be listed for transplant with UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.
Study Design This is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur within an 18-month time period at up to 40 centers. All patients will be followed for all endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or death, whichever occurs first. For those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. If patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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:
- •Approved for cardiac transplantation
- •Listed with UNOS on the Status 1 list
- •Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation
排除标准
- •The following are general criteria; more specific conditions are included in the study protocol:
- •Contraindication to the administration of warfarin or anti-platelet agents
- •Primary coagulopathy or platelet disorder
- •Acute myocardial infarction within 48 hours prior to enrollment
- •Anticipated need for RVAD support or ECMO at the time of LVAS implantation
- •Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device
结局指标
主要结局
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
时间窗: 180 days
次要结局
未报告次要终点