NCT03687723已完成不适用
Observational Study of the Clinical Use of the Organ Care System (OCS™) in Heart Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Patient Survival
研究概览
简要总结
Single-arm, prospective, multi-center observational study of the clinical use of the ex-vivo perfusion of the heart with the Organ Care System (OCS™)
详细描述
This is an observational study at two centers that will enroll minimum of 60 heart transplant recipients transplanted with donor heart preserved using the OCS™ Heart System. All consented subjects who receive OCS™-preserved heart transplants will be approached for participation. The study will evaluate short and long-term effectiveness of the OCS™ Heart System for heart transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All recipients of heart transplantation with Use of the OCS™ Heart
排除标准
- •Donor Hearts
- •Presence of coronary heart diseases
- •acute myocardial infarction
- •Presence of heart valve disease (Stenosis or Insufficiency > first degree)
- •Presence of left ventricular hypertrophy (septum and posterior wall thickness >1.7 cm)
- •State of shock of donor (MAP <60 mmHg, CVP >15, PCWP >15 mmHg) with use of Dobutamine >10 ug/kg/min and/or Norepinephrine > 0.5 ug/kg/min or Epinephrine > 0.2 ug/kg/min
- •irreversible persistant pulmonary hypertrophy, defined as transpulmonary gradient >15 mmHg of the recipient
结局指标
主要结局
Patient Survival
时间窗: 12 months
12-month patient survival post heart transplant Primary Effectiveness Endpoint
次要结局
- Patient and Graft Survival(30 days)
研究者
研究点 (1)
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