[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Shenqi Medical Technology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100579392","safety-and-effectiveness-study-of-sq-kyrin-system-for-functional-mitral-regurgitation-in-eu-100579392",false,"NCT06823700","Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU","A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Shenqi Transcatheter Mitral Valve Clips Delivery System and Steerable Guide Catheters in Patients with Functional Mitral Regurgitation","Inclusion Criteria:\n\n1. Participant who has provided written informed consent for the investigation.\n2. Age ≥18 years.\n3. Patients diagnosed with FMR.\n4. MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).\n5. LVEF ≥20% to ≤60%.\n6. Symptom status: NYHA functional class II to IV despite a stable maximally tolerated GDMT regimen as per guidelines.\n7. According to the judgment of local cardiology team, subjects have undergone adequate treatment for at least 30 days (preferably 90 days) based on the criteria recommended in the heart failure guidelines.\n8. Subject fulfils FMR anatomy selection criteria.\n9. According to the judgment of the local Cardiovascular medical-surgery team, subjects who have high or prohibitive risk for open heart surgery.\n10. Left ventricular end-systolic diameter (LVESD)≤70mm.\n11. The MR beam mainly originates from the A2\u002FP2 area.\n12. Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets\\>10mm.\n13. Mitral valve effective orifice area (EOA) ≥ 4.0cm2.\n14. No obvious calcification of main grasp mitral valve leaflets.\n15. Patient anatomy allows atrial septum approach.\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.\n2. Hypotension (systolic pressure \\\u003C90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.\n3. UNOS status 1 heart transplantation or prior orthotopic heart transplantation.\n4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.\n5. Fixed pulmonary artery systolic pressure \\>70 mm Hg.\n6. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.\n7. Mitral valve anatomy which may preclude proper device treatment.\n8. Mitral valve area \\\u003C 4.0 cm2 (if new device therapy may further decrease the mitral orifice area).\n9. Any prior mitral valve surgery or transcatheter mitral valve procedure.\n10. Stroke or transient ischemic event within 30 days before enrolment.\n11. Modified Rankin ≥ Scale 4 disability.\n12. Severe symptomatic carotid stenosis (\\>70% by ultrasound).\n13. Need for emergent or urgent intervention for any reason or any planned cardiac intervention within the next 12 months.\n14. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 1 month before enrolment.\n15. Untreated clinically significant coronary artery disease requiring revascularization.\n16. Any percutaneous cardiovascular intervention, cardiovascular intervention, or carotid intervention within 30 days\n17. Tricuspid valve disease requiring intervention or severe or more tricuspid regurgitation.\n18. Aortic valve disease requiring intervention or any concomitant treatment.\n19. Need for any cardiovascular intervention (other than for MV disease).\n20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n21. Active endocarditis.\n22. Active infections requiring current antibiotic therapy.\n23. Subjects in whom transoesophageal echocardiography is contraindicated or high risk.\n24. Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.\n25. Patient unable or unwilling to provide written, informed consent before study enrolment.\n26. Pregnant woman or woman planning to become pregnant.\n27. Patients with severe liver, renal or pulmonary disease, which in investigator opinion may have an impact on patient safety.\n28. Clinically significant lab abnormalities which in investigator opinion may have an impact on patient safety.","ALL","18 Years",{"count":19,"type":20},34,"ESTIMATED","INTERVENTIONAL",[23],"NA","The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.",[26],"Functional Mitral Regurgitation","RECRUITING","2025-02-08",{"date":30,"type":31},"2025-02-12","ACTUAL",{"date":33,"type":31},"2024-12-17",{"date":35,"type":20},"2026-12-31",{"name":37,"class":38},"Shanghai Shenqi Medical Technology Co., Ltd","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":39},"100540751","efficacy-and-safety-of-intraparenchymal-portal-vein-covered-stents-in-treating-portal-hypertension-and-its-complications-100540751","NCT06320912","Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications","A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Study Evaluating the Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents for the Treatment of Portal Hypertension and Its Complications","Inclusion Criteria:\n\n* Age 18-75 years (inclusive); male or non-pregnant female.\n* Diagnosed with cirrhosis and associated complications of portal hypertension (such as esophageal and gastric variceal bleeding, refractory ascites), and meeting the consensus recommendations for TIPS indications (see Appendix 5).\n* Participants must understand the purpose of the trial, voluntarily participate, sign an informed consent form, and be willing to complete the follow-up according to the project requirements.\n\nExclusion Criteria:\n\n* Severe right heart failure, congestive heart failure (LVEF \\\u003C 40%), or severe valvular heart dysfunction.\n* Uncontrolled systemic infection or inflammation.\n* Persistent moderate to severe pulmonary hypertension after treatment (tricuspid regurgitant peak velocity \\> 3.4 m\u002Fs or pulmonary artery systolic pressure \\> 50 mmHg).\n* Patients in hepatic encephalopathy coma or comatose phase (West Haven Criteria Stage III, IV).\n* Severe liver dysfunction, Child-Pugh score \\> 13, or MELD score \\> 18.\n* Serum creatinine (Scr) \\> 178 umol\u002FL or on dialysis.\n* Stage IIIa or higher liver malignancy.\n* Budd-Chiari syndrome, hepatic veno-occlusive disease, or obstructive cholestasis.\n* Polycystic liver disease.\n* Unrectifiable coagulopathy (INR \\> 5 or PLT count \\\u003C 20 x 10\\^9\u002FL).\n* Main portal vein thrombosis occupying \\> 50% of the lumen area or cavernous transformation of the portal vein.\n* Previous TIPS procedure or planned liver transplantation within a year.\n* Allergy to contrast agents or nickel-titanium alloys.\n* Life expectancy less than 1 year.\n* Participation in other drug or medical device clinical trials within three months before screening.\n* Other conditions deemed by the researcher as unsuitable for participation in this clinical trial.","75 Years",{"count":49,"type":20},258,[23],"The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE.",[53],"Portal Hypertension",[55],"Portal hypertension","NOT_YET_RECRUITING","2024-03-13",{"date":59,"type":31},"2024-03-20",{"date":61,"type":20},"2024-04-05",{"date":63,"type":20},"2026-11-01",{"name":37,"class":38},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":39},"100442337","sq-kyrin-tmvr-fim-study-100442337","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.",{"count":73,"type":20},20,[23],"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.",[77],"Mitral Regurgitation",[77],"2021-09-01",{"date":81,"type":31},"2021-09-10",{"date":83,"type":31},"2021-04-01",{"date":85,"type":20},"2026-10",{"name":37,"class":38},""]