Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- TransMedics
- 入组人数
- 655
- 试验地点
- 15
- 主要终点
- Patient and graft survival
研究概览
简要总结
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
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
- •Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
- •All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is <50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor.
- •DBD donor hearts with an expected cross clamp of ≥ 4 hours
- •DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time:
- •Donor age ≥ 40 years old
- •Unknown downtime
- •Insignificant CAD
- •LVEF ≤ 50%
- •Donor Exclusion • Moderate to severe aortic incompetence
- •Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication):
- •Donor Inclusion Criteria
- •Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
- •Eligible for randomization to OCS or SCS treatment arms.
- •DBD donor hearts with an expected cross clamp time of < 4 hours.
- •Donor Exclusion
- •Moderate to severe aortic incompetence
- •DBD donor with any of the following organ quality concerns:
- •Donor age ≥ 40 years old
- •Unknown downtime
- •Insignificant CAD
- •LVEF ≤ 50%
- •Recipient Eligibility Criteria (for Part A and B Cohorts)
- •Signed informed consent document and authorization to use and disclose protected health information
- •Heart transplant candidate
- •Age ≥ 18 years old
- •Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial
排除标准
- 未提供
研究组 & 干预措施
Part A (OCS Heart)
DCD Donor Hearts & DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications)
干预措施: OCS Heart (Device)
Part B (OCS Heart)
DBD Donor Hearts Currently Used with Cold Storage
干预措施: OCS Heart (Device)
Part B (SCS)
DBD Donor Hearts Currently Used with Cold Storage
干预措施: Static Cold Storage (SCS) (Other)
结局指标
主要结局
Patient and graft survival
时间窗: 30-day post transplant
The primary endpoint is 30-day patient and graft survival with freedom from moderate or severe LV or RV primary graft dysfunction (PGD) in the first 24 hours post-transplant.
次要结局
未报告次要终点