Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial. - Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial.

ational Cerebral and Cardiovascular Center0 个研究点目标入组 25 人开始时间: 2020年2月17日最近更新: 2023年10月17日

试验速览

暂无简介。

•1) Unfavorable or technically-challenging cardiac anatomy 2) Evidence of irreversible hepatic disease (except when the primary investigator deems it as a sign of acute heart failure) 3) Evidence of irreversible renal disease (except when the primary investigator deems it as a sign of acute heart failure) 4) Contraindicated for anticoagulation 5) Difficulty of 14-day observation is anticipated 6) Participating in another clinical trial at time of study entry 7) Deemed unsuitable by the primary investigator for other reasons

发起方

ational Cerebral and Cardiovascular Center