[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Valgen Medtech Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":144},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,62,84,103,124],{"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},"100482010","safety-and-effectiveness-study-of-dragonfly-t-system-for-severe-tricuspid-regurgitation-100482010",false,"NCT05556460","Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation","A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management)and has been stable for at least 30 days.\n3. Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;\n4. Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery\n5. New York Heart Association (NYHA) Cardiac function Class II-IVa;\n\n5\\. The patient is suitable for transcatheter tricuspid valve repair, suitable for the use of this study instrument, and the femoral vein access is feasible and can accommodate catheter; 6. Patient must provide written informed consent before any steps related to the study.\n\nExclusion Criteria:\n\n1. Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, including but not limited to the following:\n\n   1. Evidence of calcification in the grasping area;\n   2. Presence of a severe coaptation defect of the tricuspid leaflets;\n   3. Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL;\n   4. Epstein anomaly.\n2. Other serious heart valvular diseases requiring intervention or planning to intervention in the next 12 months; Note: If mitral and tricuspid valve lesions are combined, mitral valve surgery can be performed first, and re-evaluation can be performed 60 days after surgery.\n3. Tricuspid stenosis evaluated by ECL and\u002For cross-tricuspid differential pressure ≥ 5 mmHg;\n4. Previous tricuspid valve surgery or transcatheter therapy;\n5. Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus;\n6. TTE and TEE are unable to evaluate tricuspid valve anatomy; Participated in any drug and\u002For medical device clinical trials within 1 month prior to the trial; ……\n\n28\\. The researchers do not consider it appropriate to be enrolled in the study.","ALL","18 Years",{"count":19,"type":20},236,"ESTIMATED","INTERVENTIONAL",[23],"NA","The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (DragonFly-T system) to Control (Medical Therapy).",[26],"Tricuspid Regurgitation","RECRUITING","2026-06-10",{"date":30,"type":31},"2026-06-12","ACTUAL",{"date":33,"type":31},"2024-09-03",{"date":35,"type":20},"2032-08-15",{"name":37,"class":38},"Hangzhou Valgen Medtech Co., Ltd","INDUSTRY",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100510515","dragonfly-eu-pivotal-study-100510515","NCT05927441","DragonFly EU Pivotal Study","Safety and Performance Evaluation Study of DragonFly System for Mitral Regurgitation","Inclusion Criteria:\n\n* ≥18 years old\n* New York Heart Association (NYHA) Class II-IV\n* Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography (For DMR cohort)\n* Symptomatic FMR ≥ 3+ due to ischemic or non-ischemic cardiomyopathy (For FMR cohort)\n* Transseptal catheterization and femoral vein access are determined to be feasible\n* Subjects have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF\n\nExclusion Criteria:\n\n* Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n* Other severe heart valve diseases requiring intervention\n* Prior mitral valve leaflet surgery (prior annuloplasty ring not excluded) or previous transcatheter mitral valve intervention\n* Acute myocardial infarction occurred within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization\n* Any cardiovascular intervention within 30 days or cardiac surgery within 6 months prior to the procedure; or in the judgment of the investigator, the femoral vein cannot accommodate a 25 F catheter or the presence of an inferior vena cava filter would interfere with advancement of the catheter or ipsilateral deep vein thrombosis is present; or the patient's anatomy is not suitable for atrial septal puncture\n* Patients in whom TEE or general anesthesia is contraindicated\n* End stage heart failure (ACC\u002FAHA stage D); or after heart transplantation; or waiting for a heart transplantation\n* Active endocarditis or active rheumatic heart disease; or mitral valve changes due to endocarditis and rheumatic heart valve disease\n* History of ischemia cerebrovascular accident in the past 30 days, or severe symptomatic carotid stenosis (ultrasonic examination showed stenosis degree \\>70%); or carotid stent implantation within 30 days; hemorrhagic cerebrovascular accident occurred within 6 months\n* History of acute peptic ulcer or gastrointestinal bleeding within 3 months\n* Hemorrhagic disease or coagulation disorder; or contraindicated of antithrombotic drug treatment\n* Modified Rankin scale ≥ 4\n* Diseases that make the evaluation of treatment difficult (e.g., cancer, severe metabolic disease, psychosis)\n* Pregnant or lactating women\n* Hemodynamic instability defined as systolic pressure \\\u003C 90 mmHg without afterload reduction medicine, or cardiogenic shock, or need for an intra-aortic balloon pump, or other hemodynamic support devices\n* Active infections requiring current antibiotic therapy (if temporary illness, patients may be enrolled 2 weeks after discontinuation of antibiotics)\n* Currently participating in an investigational drug or another device study of which the primary endpoint has not been completed, or it that clinically interferes with the current study endpoints. (Note: extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational study)\n* In the judgment of the investigator, the patients' compliance will be poor and could not complete the study as required, or other conditions indicate that the subject is not suitable to participate in the study",{"count":48,"type":20},168,[23],"To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.",[52],"Mitral Valve Insufficiency","2025-11-19",{"date":55,"type":31},"2025-11-24",{"date":57,"type":31},"2024-01-01",{"date":59,"type":20},"2029-05-01",{"name":37,"class":38},1,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":61},"100611639","dragonfly-m2-pivotal-study-100611639","NCT07243197","DragonFly M2 Pivotal Study","Safety and Performance Evaluation Study of DragonFly M2 System for Mitral Regurgitation","Inclusion Criteria:\n\n1.≥ 18 years old. 2.Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography.\n\n* Transseptal catheterization is determined to be feasible by the Investigator.\n* Patients have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF.\n\nExclusion Criteria:\n\n1)Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2) The presence of other severe heart valve disease requiring surgical intervention.\n\n3\\) Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.\n\n* Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.\n* In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.",{"count":70,"type":20},53,[23],"To confirm the effectiveness and safety of the DragonFly M2 Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects.The safety and effectiveness of the first-generation device(Dragonfly Transcatheter Mitral Valve Repair System)have been previously demonstrated. This study aims to further confirm the safety and effectiveness of the new device following structural optimization based on the first-generation design.",[74],"Mitral Valve (MV) Regurgitation","NOT_YET_RECRUITING","2025-11-17",{"date":78,"type":31},"2025-11-21",{"date":80,"type":20},"2026-01-15",{"date":82,"type":20},"2031-06-30",{"name":37,"class":38},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":61},"100611636","randomized-controlled-study-of-dragonfly-system-for-functional-mitral-regurgitation-100611636","NCT07243158","Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation","A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of the DragonFly Transcatheter Mitral Valve Clip System in the Treatment of Moderate-to-Severe or Severe Functional Mitral Regurgitation (FMR)","Inclusion Criteria:\n\n1\\) Age ≥ 18 yrs. 2) Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy\n\n* Transseptal catheterization and femoral vein access is determined to be feasible.\n* The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.\n\nExclusion Criteria:\n\n1\\) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2）Echocardiography revealed severe restriction of leaflet motion due to tethering.\n\n3\\) The presence of other severe heart valve disease requiring surgical intervention.\n\n* Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.\n* In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.",{"count":92,"type":20},148,[23],"To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.",[96],"Mitral Regurgitation Functional",{"date":78,"type":31},{"date":99,"type":20},"2025-12-30",{"date":101,"type":20},"2030-06-30",{"name":37,"class":38},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":61},"100544373","feasibility-study-of-the-dragonfire-for-hypertrophic-obstructive-cardiomyopathy-100544373","NCT06368037","Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy","To Evaluate the Safety and Feasibility of the DragonFire Transcatheter Radiofrequency Myocardial Ablation System","Inclusion Criteria:\n\n* (1) Age ≥18 years; (2) Diagnosis of obstructive hypertrophic cardiomyopathy, with a peak left ventricular outflow tract gradient (LVOTG) ≥50mmHg at rest or with provocation; (3) Significant clinical symptoms including fatigue, dyspnea, exertional angina, syncope, severely affecting quality of life, and either inadequate response to standardized drug therapy or inability to tolerate drug side effects, with anatomical suitability for alcohol septal ablation and myocardial radiofrequency ablation system and use of catheter-based myocardial radiofrequency ablation needle and its guidance system; (4) NYHA functional class ≥III, or NYHA functional class II patients with one of the following: ① Severe progressive pulmonary arterial hypertension caused by outflow obstruction or resulting mitral regurgitation; ② Atrial fibrillation with associated left atrial enlargement; ③ Exercise treadmill testing indicating reduced cardiac function due to outflow obstruction; (5) Judged by the local clinical trial institution research team as high surgical risk (recommended reference criteria: advanced age or severe comorbidities, or presence of other surgical high-risk factors, such as: ≥2 moderate to severe frailty indicators or potential surgical obstacles, or ≥1 major organ dysfunction that cannot be improved after surgery, or other surgical high-risk factors judged by the cardiac team), or patients who, after being fully informed of the risks and benefits of surgery by the research team, still refuse to undergo surgery; (6) Expected survival of more than 12 months and able to adhere to the follow-up plan; (7) The subject has been informed of the nature of the study, understands the purpose of the clinical trial, voluntarily participates, and signs the informed consent form.\n\nExclusion Criteria:\n\n* (1) Non-obstructive hypertrophic cardiomyopathy and end-stage hypertrophic cardiomyopathy; (2) Interventricular septum thickness \\\u003C15mm; (3) Significant diffuse thickening of the interventricular septum; (4) 5-year sudden cardiac death risk score (SCDI) ≥10%, or history of cardiac sudden death (SCD) events, or ventricular fibrillation, or sustained ventricular tachycardia leading to loss of consciousness, or ventricular arrhythmias causing hemodynamic instability in patients without an implanted ICD; (5) Left ventricular ejection fraction \\\u003C50%; (6) Transthoracic echocardiography suggesting the presence of intracavitary masses, thrombi, or vegetations; (7) History of surgical septal myectomy, alcohol ablation, or other interventricular septal ablation procedures; (8) Any cardiovascular intervention within 30 days or cardiac surgery within 6 months; (9) Concurrent presence of other cardiac diseases requiring surgical treatment, such as severe mitral valve disease, multi-vessel coronary artery disease, etc.; (10) Acute heart failure (defined as acute hemodynamic abnormalities occurring on the basis of primary cardiac or non-cardiac diseases, resulting in a clinical syndrome primarily characterized by acute pulmonary edema, cardiogenic shock, and elevated plasma levels of B-type natriuretic peptide) or end-stage heart failure (defined as resting heart failure, intractable pulmonary edema, or pleural or pericardial effusion despite intensified anti-heart failure treatment); (11) Preoperative presence of right bundle branch block, left bundle branch block, or atrioventricular block requiring permanent pacemaker implantation, or previously implanted permanent cardiac pacemaker; (12) Significant coronary artery disease or critical lesions requiring revascularization due to coronary perfusion-demand mismatch (QFR or FFR \\\u003C0.8), or those experiencing ischemic events within 30 days; (13) Vascular diseases affecting access for investigational devices, such as aortic aneurysm, severe aortic stenosis, severe aortic arch or aortic valve calcification, or tortuosity or stenosis of the iliac artery; (14) Inability to determine target septal branch or balloon not being fixable in the septal branch, or cardiac anatomy unsuitable for alcohol septal ablation; (15) Hemodynamic instability, defined as systolic blood pressure \\\u003C90mmHg without the use of afterload-reducing drugs accompanied by symptoms of hypoperfusion, or cardiogenic shock; or requiring vasopressor therapy; or requiring intra-aortic balloon counterpulsation; or other hemodynamic support devices; (16) History of acute peptic ulcer or gastrointestinal bleeding within 3 months; (17) Severe chronic obstructive pulmonary disease (COPD) (requiring continuous home oxygen therapy or long-term use of corticosteroids); (18) History of ischemic cerebrovascular accident (within the past 30 days), or severe carotid artery stenosis (ultrasound showing unilateral carotid artery stenosis \\>70%), or carotid artery stent implantation within 30 days, or history of hemorrhagic cerebrovascular accident (within 6 months); (19) Bleeding disorders or coagulation disorders, or contraindications to antithrombotic therapy; (20) Renal insufficiency (serum creatinine \\>2.0mg\u002FdL or 177 µmol\u002FL or eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 or undergoing dialysis treatment; (21) Active infection requiring concurrent antibiotic therapy (if temporary, patients must discontinue antibiotic use for at least 14 days before enrollment); (22) Planned pregnancy, pregnant, or lactating females; (23) Contraindications to transesophageal echocardiography or general anesthesia; (24) Expected lifespan less than 12 months, or disease that would make evaluation of treatment difficult (such as cancer, severe metabolic diseases, psychiatric disorders, etc.) unable to complete the study as required, or poor compliance as judged by the researcher; (25) Currently participating in another experimental drug or medical device clinical study with unfinished primary endpoints or clinical studies that may interfere with the endpoints of this study; (26) Other circumstances judged by the researcher as unsuitable for participation in this study.",{"count":111,"type":20},10,[23],"This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively.",[115],"Obstructive Hypertrophic Cardiomyopathy","2024-04-11",{"date":118,"type":31},"2024-04-16",{"date":120,"type":20},"2024-08",{"date":122,"type":20},"2026-06",{"name":37,"class":38},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":61},"100418798","safety-and-effectiveness-study-of-dragonfly-system-for-functional-mitral-regurgitation-100418798","NCT04733404","Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation","A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Functional Mitral Regurgitation (FMR) Subjects.","Inclusion Criteria:\n\n1. Age ≥ 18 yrs.\n2. Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy Note 1: Functional MR requires the presence of overall or localized LV wall motion abnormalities that are considered to be the primary cause of MR. Despite the eligibility, subjects may not enroll if leaflet prolapse or other evidence of degenerative MR is present.\n\n   Note 2: An Eligible transthoracic echocardiography must be obtained at least 30 days after the subject has been stabilized on optimal therapy with Guideline Directed Medical Therapy (GDMT), and after meeting two of the following conditions:\n   1. GDMT dose increase of no greater than 100% or decrease of no greater than 50%.\n   2. Coronary revascularization and\u002For implantation of a cardiac resynchronization therapy device (CRT or CRT-D) or reprogramming of the implanted CRT or CRT-D resulting in an increase in biventricular pacing (from \\\u003C92% to ≥92%).\n3. Subjects have been adequately treated according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), coronary revascularization, and\u002For have received stable GDMT, as defined in (Appendix IV: Definition of GDMT), confirmed by the local heart team.\n4. NYHA functional class II to IVa.\n5. Left ventricular ejection fraction (LVEF) ≥ 20% and ≤50%.\n6. Left ventricular end-systolic dimension (LVESD) ≤ 70 mm.\n7. Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the DragonflyTM device.\n8. Elevated BNP \\>150 pg\u002Fml or corrected NT-proBNP ≥600 pg\u002Fml or heart failure hospitalization within the past 12 months ('corrected' refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg\u002Fm2 in BMI above a reference BMI of 20 kg\u002Fm2).\n9. Transseptal catheterization and femoral vein access is determined to be feasible.\n10. The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n2. The presence of other severe heart valve disease requiring surgical intervention.\n3. Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.\n4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.), or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.\n5. Moderate to severe right heart dysfunction or an estimated pulmonary artery systolic pressure (PASP) \\> 70 mmHg assessed by echocardiography.\n6. History of acute myocardial infarction in the prior 4 weeks or untreated clinically significant coronary artery disease requiring revascularization.\n7. Any percutaneous cardiac intervention within the 30 days, or any cardiac surgery within the 6 months prior to randomization, or any implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) or Implantable Cardioverter Defibrillator (ICD) within the last 30days prior to subject registration.\n8. In the judgment of the investigator, the subject's femoral vein is unable to accommodate a 25F catheter or has an ipsilateral deep venous thrombosis; or the anatomy is not accessible for transseptal puncture.\n9. Subjects in whom transesophageal echocardiography (TEE) or general anesthesia is contraindicated.\n10. End-stage heart failure (ACC\u002FAHA stage D), or prior orthotopic heart transplantation, or on the waiting list for heart transplantation.\n11. Active endocarditis, or active rheumatic heart disease, or leaflets degenerated from either endocarditis or rheumatic disease.\n12. Severe Chronic Obstructive Pulmonary Disease (COPD) (requiring continuous home oxygen therapy or long-term application of steroid hormone medication).\n13. Cerebrovascular accident within 30 days prior to randomization or symptomatic severe carotid stenosis (\\> 70% by ultrasound), or carotid artery stenting within 30 days.\n14. Evidence of acute peptic ulcer or gastrointestinal hemorrhage in the prior 3 months.\n15. Hemorrhagic or coagulopathic disorders, contraindications to antithrombotic medication.\n16. Modified Rankin Scale ≥4.\n17. The subjects suffer from diseases that may lead to difficulty in evaluating treatment (e.g., cancer, severe metabolic disease, psychosis, etc.).\n18. Pregnant or breastfeeding women, or women who plan to become pregnant within the next 12 months. Note: Women of childbearing age should take a pregnancy test with a negative result within 14 days prior to registration and use scientifically safe contraception\n19. Hemodynamic instability defined as systolic pressure \\\u003C 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or an intra-aortic balloon pump.\n20. Active infections requiring antibiotic therapy (in the case of temporary illness, antibiotics must be discontinued for at least 14 days before the subject can be enrolled).\n21. Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.\n22. In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.",{"count":132,"type":20},120,[23],"To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.",[96],"2022-03-26",{"date":138,"type":31},"2022-03-29",{"date":140,"type":31},"2022-03-12",{"date":142,"type":20},"2027-09-30",{"name":37,"class":38},""]