Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of mortality
研究概览
简要总结
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.
详细描述
The registry study has an observational, prospective, international, multi-center, non-randomized design.
The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.
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
- •Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,
- •The indications on RVAD and BVAD use of the EXCOR VAD apply,
- •Patient shall be on transplant list or at least eligible for HTx,
- •BSA (body surface area) greater than or equal to 1.2 m².
排除标准
- •Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
- •The contraindications of EXCOR VAD apply.
结局指标
主要结局
Rate of mortality
时间窗: 30 days
Short-term mortality
Survival to heart transplantation
时间窗: up to 12 months
Long-term survival to heart transplantation
Rate of major bleeding
时间窗: 30 days
Short-term rate of major bleeding
Rate of thrombosis
时间窗: 30 days
Short-term rate of thrombosis
次要结局
- Rate of adverse events(up to 12 months)