NCT07243184招募中不适用
A Prospective, Multicenter Clinical Trial Evaluating the Feasibility and Safety of Polymer Artificial Heart Valve for the Treatment of Mitral Valve Diseases
Shanghai HeartEpoch Medical Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年11月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The composite incidence rate of all-cause mortality and reoperation
研究概览
简要总结
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 60 years old;
- •severe mitral regurgitation or severe mitral stenosis confirmed by ECHO;
- •surgical mitral valve replacement;
排除标准
- •LVEF < 50%;
- •History of cardiac surgery or history of cardiac intervention( within 1 year), Concurrent cardiac surgery(excluding tricuspid valve repair surgery or atrial fibrillation ablation) or cardiac interventional procedures;
- •intracardiac mass, thrombus or neoplasm confirmed by echo;
- •Coronary artery disease that requires revascularization；
- •A pacemaker need to be implanted;
- •Severe macrovascular lesions require surgical treatment;
- •Patients with active bleeding, bleeding tendencies or those who are unable to receive anticoagulant therapy；
- •There was evidence of acute myocardial infarction within 1 month before the surgery (Q-wave MI or non-Q-wave MI, CK-MB ≥ twice the normal level and/or elevated troponin)；
- •here was a history of cerebrovascular events (CVA) within 1 month before the surgery, including ischemic and hemorrhagic strokes, but excluding transient ischemic attacks (TIA);
- •Confirmed or suspected diagnosis of infective endocarditis or other active infections;
- •There are diseases that significantly affect the evaluation of treatment, such as patients with neurological disorders that affect cognitive abilities, and patients with malignant tumors and an expected lifespan of no more than one year；
- •Other situations in which patients are not suitable to participate in this trial.
研究组 & 干预措施
Polymer Artificial Heart Valve
Experimental
Device: Polymer Artificial Heart Valve Mitral valve replacement
干预措施: mitral valve replacement (Device)
结局指标
主要结局
The composite incidence rate of all-cause mortality and reoperation
时间窗: 3 months
次要结局
- The change of 6 minutes walk testing(6MWT) from baseline(3months, 6months)
- The change of NYHA from basement(7 days after operation, 30 days after operation, 3 months after operation)
- Implantation success rate(after the operation)
- The improvement of 6 minutes walk testing(6MWT) from baseline(3months, 6months)
- Performance evaluation of implanted valves(1 day after operation, 7 days after operation, 1 months after operation, 3 months after operation.)
- The improvement of NYHA from basement(7 days after operation, 30 days after operation, 3 months after operation)
研究者
Jiangang Wang
Director of valve and AF surgical center
Beijing Anzhen Hospital
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart ValvePulmonary Valve InsufficiencyNCT05809856Charite University, Berlin, Germany7
尚未招募
不适用
Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve DiseaseAortic Valve StenosisAortic Valve DiseaseAortic Valve RegurgitationNCT06737757Suzhou Hearthill Medical Technology Co.,LTD198
已完成
不适用
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic ValveAortic Valve StenosisAortic Valve Stenosis With InsufficiencyRegurgitation, Aortic ValveAortic Valve IncompetenceNCT01700439Edwards Lifesciences934
已完成
不适用
Medtronic CoreValve REDO StudyAortic Valve StenosisNCT01051310Medtronic Cardiac Rhythm and Heart Failure18
撤回
不适用
Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR SystemMitral RegurgitationNCT03714412Cardiovalve Ltd.