PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 141
- 试验地点
- 26
- 主要终点
- The percentage of patient treatment success rate
研究概览
简要总结
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.
详细描述
PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).
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
- •Recipient Inclusion Criteria:
- •Age ≥18 years.
- •Signed informed consent form (ICF).
- •Listed for heart transplantation
排除标准
- •Previous solid organ or bone marrow transplantation.
- •Requires a multi-organ transplant.
- •Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
- •Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump.
- •History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion).
- •Subject on renal replacement therapy/dialysis.
- •Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
- •Sensitized subject is undergoing desensitization treatment.
- •Donor Inclusion Criteria:
- •Estimated Cross Clamp Time ≥ 4 hours, OR
- •Estimated Cross Clamp Time ≥ 2 hours, AND
- •Any ONE or more of the following:
- •Age ≥ 50 years
- •LVEF 40-50% at time of provisional acceptance
- •Down-time ≥ 20 mins
- •Hypertrophy/Septal thickness >12- ≤16mm
- •Angiographic luminal irregularities with no significant CAD, OR
- •Donation after Circulatory Death (DCD) donors.
- •Donor Exclusion Criteria:
- •Unstable hemodynamics requiring high-dose inotropic support.
- •Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels.
- •Moderate to severe cardiac valve pathology.
- •Investigator's clinical decision to exclude from trial.
- •Previous Sternotomy.
研究组 & 干预措施
Subjects requiring a Heart Transplant
Device: Preservation of hearts for transplant.
干预措施: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) (Device)
结局指标
主要结局
The percentage of patient treatment success rate
时间窗: 30 days post transplantation
The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.
The percentage of patient survival
时间窗: Post-operative Day 365.
The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.
次要结局
未报告次要终点