[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593442":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":60,"collaborators":25,"id":62,"slug":25,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"SuZhou Sinus Medical Technologies Co.,Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Septal RF Ablation Group","EXPERIMENTAL","Participants in this group will receive a transcatheter intramyocardial septal radiofrequency ablation under intracardiac echocardiography (ICE) guidance using the investigational device system. Standardized pharmacological therapy will be continued throughout the study period.",[13],"Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Procedure (No RF Ablation)","SHAM_COMPARATOR","Participants in this group will undergo a sham procedure under ICE guidance. The catheter will be inserted but no ablation will be performed. Participants will continue standardized pharmacological therapy throughout the study period. After completion of the 6-month follow-up, participants in this arm may voluntarily choose to receive the investigational treatment.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Transcatheter Intramyocardial Septal Radiofrequency Ablation System","The device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE).",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Changshen Ma, Doctor","Capital Medical University Affiliated Beijing Anzhen Hospital","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Yongxin Su","CONTACT","+86 18121015668","suyongxin@sinusmedtech.com",[38,50],{"facility":29,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"RECRUITING","Beijing","Beijing Municipality","100029","China",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},{"facility":51,"status":39,"city":52,"state":53,"zip":54,"country":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":25},"Sir Run Run Shaw hospital","Hangzhou","Zhejiang","310016",{"type":45,"coordinates":56},[57,58],120.16142,30.29365,{"lat":58,"lon":57},{"type":61,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100593442",false,"NCT07006493","REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy","A Prospective, Multicenter, Randomized, Parallel-Controlled Superiority Study Evaluating the Efficacy and Safety of a Transcatheter Intramyocardial Septal Radiofrequency Ablation System in Patients With Obstructive Hypertrophic Cardiomyopathy","REFINE-HCM","Inclusion Criteria:\n\n* Age 18 to 80 years, regardless of sex\n* Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM)\n* Presence of significant symptoms (e.g., dyspnea, chest pain, fatigue, palpitations, syncope)\n* NYHA class II or higher with LVOTG ≥50 mmHg at rest or provoked (assessed by echocardiography)\n* Septal thickness ≥15 mm\n* Unsuitable for surgical myectomy or refusal of surgery\n* Provided informed consent and agree to complete follow-up\n\nExclusion Criteria:\n\n* Asymptomatic or non-obstructive HCM\n* Septal thickness ≥30 mm\n* Mitral valve anatomy not suitable for ablation as judged by investigator\n* High risk of sudden cardiac death (SCD) requiring ICD implantation\n* Complete right bundle branch block at screening\n* Infective endocarditis, myocarditis, atrial myxoma, or intracardiac thrombus\n* Contraindication to transseptal access (e.g., septal patch)\n* Mechanical valves or history of aortic valve replacement\n* Severe heart failure with persistent symptoms and LVEF \\\u003C40%\n* Major cardiac events within 6 months (e.g., cardiac arrest, MI, heart failure hospitalization)\n* Significant structural heart disease requiring surgery\n* Prior septal reduction therapy or pacemaker implantation\n* Constrictive pericarditis or significant congenital heart disease\n* Bleeding disorders or contraindication to antithrombotic therapy\n* Liver dysfunction (ALT\u002FAST \\>3× ULN)\n* Renal insufficiency (creatinine \\>2.0 mg\u002FdL or on dialysis)\n* Pregnant, breastfeeding, or planning pregnancy within 6 months post-op\n* Life expectancy \\\u003C12 months\n* Participation in other investigational studies within 30 days or 5 half-lives\n* Investigator determines poor compliance or unsuitability\n* Contraindications to cardiac MRI (e.g., ICD, allergy to contrast, claustrophobia)","ALL","18 Years","80 Years",{"count":73,"type":74},124,"ESTIMATED","INTERVENTIONAL",[77],"NA","This is a prospective, multicenter, randomized, parallel-controlled, superiority clinical trial designed to evaluate the efficacy and safety of a transcatheter intramyocardial septal radiofrequency ablation system for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM). Eligible participants will be randomized in a 2:1 ratio to receive either active ablation under intracardiac echocardiographic guidance or a sham procedure. All participants will continue to receive standard-of-care medical therapy during the study period. The primary endpoint is the treatment effectiveness rate at 6 months, defined as a ≥50% reduction in LVOT gradient from baseline or a resting LVOT gradient \\\u003C30 mmHg.",[80],"Hypertrophic Cardiomyopathy, Obstructive","2025-12-05",{"date":83,"type":84},"2025-12-15","ACTUAL",{"date":86,"type":84},"2025-07-20",{"date":88,"type":74},"2027-12-30",{"name":5,"class":6},2]