protocolSection identificationModule nctId: NCT06277960, orgStudyIdInfo id: CNS2301, briefTitle: Septal Ablation for Obstructive HCM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: SuZhou Sinus Medical Technologies Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited.Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches.The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy., conditionsModule conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: percutaneous intramyocardial septal radiofrequency ablation system, outcomesModule primaryOutcomes measure: 30-day major adverse clinical events (MACE), secondaryOutcomes measure: Technical success rate, secondaryOutcomes measure: Short Form 36 (SF-36) health survey questionnaire, secondaryOutcomes measure: Improvement of left ventricular outflow tract gradient (LVOTG), secondaryOutcomes measure: Improvement of NYHA functional classification, secondaryOutcomes measure: 6-min walk distance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sir Run Run Shaw Hospital, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, contacts name: Yaxun Sun, MD, role: CONTACT, phone: +86 15057173170, email: sunyaxun@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False