NCT03831048已完成不适用
Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TransMedics
- 入组人数
- 180
- 试验地点
- 25
- 主要终点
- Survival
研究概览
简要总结
To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
详细描述
A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 [SOC1] and Standard of Care 2 [SOC2] - from both randomized and concurrent control groups), adjusting for differences in risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Donor Inclusion
- •Maastricht Category III DCD donor, defined as expected death after the withdrawal of life- supportive therapy (WLST)
- •Donor age 18-49 years old inclusive
- •Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to aortic cross-clamp and administration of cold cardioplegia in the donor.
- •Donor Exclusion
- •Previous cardiac surgery
- •Known coronary artery disease
- •Cardiogenic shock or myocardial infarction, or
- •Sustained terminal ejection fraction (EF) of ≤ 50%, or
- •Significant valve disease except for competent bicuspid aortic valve
- •Recipient Inclusion
- •Primary heart transplant candidates
- •Age ≥ 18 years old
- •Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data.
- •Recipient Exclusion
- •Prior solid organ or bone marrow transplant
- •Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- •Multi-organ transplant
- •Investigator unwilling to randomize to either arm.
排除标准
- 未提供
研究组 & 干预措施
DCD Heart Possible
Experimental
干预措施: OCS Heart System (Device)
Standard of Care Heart Only
Active Comparator
干预措施: Cold Storage (Other)
结局指标
主要结局
Survival
时间窗: 6 months
Patient survival 6 months post-transplant
次要结局
- Utilization Rate(Within 24 hours post-transplant)
研究者
研究点 (25)
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