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2022年6月23日，首都医科大学附属北京安贞医院（以下简称安贞医院）与苏州心擎医疗技术有限公司（以下简称心擎）在北京、苏州两地线上连线，隆重召开体外心室辅助系统临床试验项目启动会。这是继同年3月22日，安贞医院与心擎医疗就膜式氧合器（ ECMO）及其附件项目开展临床研发合作之后，启动的第二个临床研究项目。 安贞医院副院长侯晓彤、安贞医院心肺移植中心副主任贡鸣、安贞医院科研处处长岳花兰、带领安贞医院心外科、心内科与ECMO三个临床专家团队在北京会场出席启动会。心擎医疗创始人徐博翎博士、心擎医疗副总裁颜翊凡、心擎医疗副总裁吴楠，带领心擎医疗研发与临床两个部门的相关团队在苏州分会场线上连线，参加本次临床试验项目启动会。 安贞医院副院长侯晓彤为启动会致开幕词，介绍了国外体外心室辅助系统领域已获批上市的产品与技术迭代，以及国内目前在心衰治疗领域技术研发与应用上的现状与问题。由于国内未有具备自主知识产权的产品，目前国内临床使用的产品均为国外产品，技术仍滞留在第一、二代研发阶段。又或者是运用 ECMO 作为替代，用于心外科术后病人的左心单心室辅助。但 ECMO 对人体造成的损伤较大，有较强的血液破坏性，同时术后管理较为复杂。 此次心擎体外心室辅助系统为第三代全磁悬浮技术。与第一代机械轴承泵以及第二代液力悬浮泵相比，第三代全磁悬浮技术因能消除轴承与血液的接触，血栓形成风险更低，具备更优的血液相容性，抗震性更强。而与 ECMO 相比，体外心室辅助系统在血液相容性、护理难度、心脏卸负荷等各个方面具备更明显的优势，可以更好地服务到合适的病患。 侯晓彤副院长强调，临床研究既要严格遵守临床入组要求，也要尽快完成入组、数据分析等工作，加快国内体外心室辅助装置的研究速度，为拯救更多国内心衰病患奠定扎实的医学基础。 心擎医疗创始人徐博翎博士介绍了目前心擎体外心室辅助装置的研发进展。心擎体外心室辅助装置又称体外全磁悬浮 人工心脏 （MoyoAssist® Extra-VAD ），是我国第一个自主研发的国产体外全磁悬浮人工心脏。截止目前，心擎医疗在多个临床中心研究进展顺利，已拯救多名患者。心擎医疗将与安贞医院深化合作，全面高效完成首个拥有国内自主知识产权的体外心室辅助系统的临床研究工作，促进产品早日注册上市，服务国内广大患者，并期待将中国的成功经验与世界分享。 心擎医疗副总裁颜翊凡为在场的专家医师们进行了详细的产品介绍以及使用展示，并实时解答专家医师们对于产品的一些疑问。随后，安贞医院心肺移植中心副主任贡鸣详细讲解临床试验的方案，并系统梳理了研究设计中应当注意的事项，两地参会人员就重点事项进行充分讨论。 体外心室辅助系统临床启动会就此圆满结束，标志着北京安贞医院与心擎医疗体外心室辅助系统临床试验正式启动，并开始招募受试者。

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