Condition: Mitral Regurgitation (MR) · Sponsor: Mitrassist Lifesciences Limited Co., Ltd.
The goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System. It aims to learn if the device is safe and if it can help adults who have a severe leaky heart valve (mitral regurgitation). This study is for people who are at high risk for traditional open-heart surgery. The main questions it aims to answer are: Is the MitraFix system safe for participants? Can the device be successfully placed in the heart? Does the device help reduce the valve leak and improve daily life? Participants will: Receive the MitraFix valve through a small tube inserted into a vein in the leg. Visit the clinic for heart tests, walking tests, and health checks for up to one year after the procedure.
This description comes directly from the study's public registry record.
NaXin Di · 021-69925338 · tina.ti@mitrassist.com.cn
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| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing, Beijing Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07501234