[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442337":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":20,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Shanghai Shenqi Medical Technology Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SQ-Kyrin TMVr Feasibility Study","EXPERIMENTAL","Experimental group is allocated to use the transcatheter edge-to-edge valve repair system of Shanghai Shenqi Medical Technology Co., Ltd.",[13],"Device: SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System","Transesophageal echocardiography-guided, implantable mitral valve clip repair system",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Grace Gu","CONTACT","13636491192","guchaojun@sqmedical.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"General Hospital of Northern Theater Command, PLA","RECRUITING","Shenyang","Liaoning","123005","China","CN",{"type":37,"coordinates":38},"Point",[39,40],123.43278,41.79222,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":20,"phoneExt":20,"email":20},"Yaling Han, PhD",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100442337","sq-kyrin-tmvr-fim-study-100442337",false,"NCT05040074","SQ-Kyrin TMVr FIM Study","SQ-Kyrin Transcatheter Mitral Valve Repair System Feasibility Study","Inclusion Criteria:\n\n1. Severe mitral valve regurgitation ≥ 3+ (moderate-to-severe mitral regurgitation disease);\n2. Patients with high or prohibitive risk for conventional open thoracic surgery as defined by STS risk scoring result; subjects who are judged as not tolerating mitral valve surgery due to STS procedural mortality risk ≥ 8% for mitral valve replacement or presence of any of the following risk factors:\n\n   1. Porcelain aorta or active ascending aortic atheroma\n   2. Prior radiation therapy to mediastinum\n   3. History of mediastinitis\n   4. Left ventricular ejection fraction (LVEF) \\\u003C 40%\n   5. Presence of unobstructed coronary artery bypass graft\n   6. History of 2 or more cardiothoracic surgeries\n   7. Liver cirrhosis\n   8. Other surgical risk factors\n3. Degenerated MR patients, or functional MR patients who have received guideline-directed medical therapy (GDMT therapy)\n4. Age ≥ 18 years, male or female;\n5. Patients who are at extremely high risk or not suitable for conventional mitral valve surgery, as assessed by a multidisciplinary heart team (including at least one cardiac surgeon and one cardiologist);\n6. Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the SQ-Kyrin device;\n7. Patients who can understand the objectives of the trial, volunteer to participate in the study, sign the informed consent form, and are willing to receive related examinations and clinical follow-up.\n\nExclusion Criteria:\n\n1. History of cardiac and mitral valve surgeries;\n2. Infective endocarditis or evidence of active infection;\n3. Mitral valve stenosis;\n4. Severe uncontrolled coronary artery disease;\n5. Pulmonary artery hypertension (systolic pulmonary artery pressure \\> 70 mmHg);\n6. Severe right cardiac insufficiency;\n7. LVEF \\\u003C 30%;\n8. Cardiac function of NYHA Class IV;\n9. Patient is extremely week to tolerate surgery under general anesthesia, or in a shock state indicating circulatory support;\n10. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;\n11. Chronic dialysis;\n12. Definite coagulation disorder and severe coagulation system diseases;\n13. Clear contraindications for use of anticoagulants;\n14. Cerebral stroke or transient ischemic attack in the past 30 days;\n15. Any cardiac mass, left ventricular or atrial thrombosis identified by echocardiography;\n16. Other valve diseases that requiring surgery or intervention;\n17. Severe macrovascular disease requiring surgical treatment;\n18. Treatment-naive carotid artery stenosis \\> 70%;\n19. Imaging evidence of inappropriate cardiac and valve anatomy;\n20. Known hypersensitivity to contrast media, and nickel-titanium memory alloy products;\n21. Severe nervous system disorder compromising the cognitive ability;\n22. Life expectancy \\\u003C 12 months;\n23. Severe thorax deformity;\n24. Pregnant and lactating women.","ALL","18 Years",{"count":57,"type":58},20,"ESTIMATED","INTERVENTIONAL",[61],"NA","A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.",[64],"Mitral Regurgitation",[64],"2021-09-01",{"date":68,"type":69},"2021-09-10","ACTUAL",{"date":71,"type":69},"2021-04-01",{"date":73,"type":58},"2026-10",{"name":5,"class":6},1]