SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 52
- 主要终点
- Probable Benefit (for Pediatric Arm); Efficacy (for Adult Arm)
研究概览
简要总结
The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support transplant-eligible adult patients (aged 19 - 75 years) at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits.
The study will be conducted as a three-arm trial of the 50cc temporary Total Artificial Heart (TAH-t) as a bridge to transplant:
- The Primary Pediatric Arm of the trial will evaluate the safety and probable benefit of the 50cc TAH-t for transplant-eligible patients 10 through 18 years of age.
- The Primary Adult Arm of the trial will evaluate the safety and efficacy of the 50cc TAH-t for transplant-eligible patients 19 through 75 years of age.
- The Secondary Arm will capture pediatric and adult subjects who did not meet enrollment criteria for a Primary Arm, but meet the less restrictive Secondary Arm enrollment criteria, in order to further characterize the use of the device.
详细描述
Heart failure is the reduced ability of the native heart to pump blood and maintain normal bodily function. Heart transplantation is the standard of care treatment for end-stage heart failure but the supply of donor hearts is insufficient to meet the need and many patients are not eligible for transplantation because of age or comorbid conditions.
On 15 October 2004, the SynCardia 70cc temporary TAH-t System received Food and Drug Administration (FDA) approval for Premarket Approval Application (PMA) #P030011 for in-hospital use as a bridge to transplant (BTT) in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. The system consists of the implantable TAH-t and an external pneumatic driver. Subsequent to the original approval, two additional external pneumatic drivers have been approved for use with the 70cc TAH-t.
On 30 January 2013, FDA granted a Humanitarian Use Designation (HUD) to the 50cc TAH-t for use as BTT in pediatric patients with biventricular heart failure who have a body surface area (BSA) that can sufficiently accommodate the device. To evaluate the ability of the device to support patients who are too small to be supported with the 70cc TAH-t, SynCardia will conduct a clinical study.
The study will be conducted as a three-arm trial of the 50cc temporary Total Artificial Heart (TAH-t) as a bridge to transplant:
- The Primary Pediatric Arm of the trial will evaluate the safety and probable benefit of the 50cc TAH-t for transplant-eligible patients 10 through 18 years of age.
- The Primary Adult Arm of the trial will evaluate the safety and efficacy of the 50cc TAH-t for transplant-eligible patients 19 through 75 years of age.
- The Secondary Arm will capture pediatric and adult subjects who did not meet enrollment criteria for the pediatric arm, but meet the less restrictive Secondary Arm enrollment criteria, in order to further characterize the use of the device.
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
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients who are not cardiac transplant-eligible
- •Cardiac transplant-eligible patients
- •Who cannot be adequately anticoagulated on the TAH-t
- •With insufficient space in the chest
- •Who are on extracorporeal membrane oxygenation (ECMO) support > 3 days
- •Patients who are being supported by an investigational device at the time of evaluation for a 50cc TAH-t
- •Patients who have required cardiopulmonary resuscitation (CPR) for > 30 minutes within 14 days prior to proposed implant
- •Patients who have experienced a stroke within 30 days prior to proposed implant
- •Patients who are dialysis-dependent at time of proposed implant
- •Inclusion Criteria, Secondary Arm (pediatric and adult patients)
- •Not eligible for Primary Arm
- •At imminent risk of death from biventricular heart failure
- •With Body Surface Area (BSA) of 1.2 through 1.85m2
- •With adequate sternum to T10 distance OR Adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
- •Exclusion Criteria, Secondary Arm:
- •Patients who are not cardiac transplant-eligible
- •Cardiac transplant-eligible patients
- •Who cannot be adequately anticoagulated on the TAH-t
- •With insufficient space in the chest
- •Patients who are being supported by an investigational device at the time of evaluation for a 50cc TAH-t
结局指标
主要结局
Probable Benefit (for Pediatric Arm); Efficacy (for Adult Arm)
时间窗: 6 months
Probable benefit will be measured at six months post-implant as either transplanted during the first six months, or continuing on support at six months on the same 50cc TAH-t, without experiencing permanent disabling stroke-related deficits.
次要结局
- Safety: Performance Goal of Four Adverse Event Categories(Six months)