Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-07 @ 1:23 PM
Study NCT ID:
NCT07006493
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and outcomes assessors are blinded to group assignment until completion of the 6-month primary endpoint assessment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Effectiveness Rate at 6 Months', 'timeFrame': '6 months post-procedure', 'description': 'Defined as either (1) a ≥50% reduction in resting LVOT gradient from baseline, or (2) resting LVOT gradient \\<30 mmHg.'}], 'secondaryOutcomes': [{'measure': 'Change in Resting LVOT Gradient', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Measured by echocardiography at baseline, 6 months, and 12 months'}, {'measure': 'Change in NYHA Functional Class', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Proportion of patients with improvement of ≥1 NYHA class'}, {'measure': 'Change in 6-Minute Walk Distance', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Distance walked in 6 minutes, compared to baseline'}, {'measure': 'Change in 12-Item Short Form Health Survey (SF-12) Score', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'The SF-12 Health Survey includes two components: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better health status.'}, {'measure': 'Device Success Rate', 'timeFrame': 'Day of procedure', 'description': 'Defined as successful completion of RF ablation per protocol'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Through 12 months', 'description': 'All adverse events related to device or procedure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertrophic Cardiomyopathy, Obstructive']}, 'descriptionModule': {'briefSummary': '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 \\<30 mmHg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\<40%\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/AST \\>3× ULN)\n* Renal insufficiency (creatinine \\>2.0 mg/dL or on dialysis)\n* Pregnant, breastfeeding, or planning pregnancy within 6 months post-op\n* Life expectancy \\<12 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)'}, 'identificationModule': {'nctId': 'NCT07006493', 'acronym': 'REFINE-HCM', 'briefTitle': 'REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'SuZhou Sinus Medical Technologies Co.,Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CRCT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Septal RF Ablation Group', 'description': '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.', 'interventionNames': ['Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Procedure (No RF Ablation)', 'description': '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.', 'interventionNames': ['Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System']}], 'interventions': [{'name': 'Transcatheter Intramyocardial Septal Radiofrequency Ablation System', 'type': 'DEVICE', 'description': 'The device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE).', 'armGroupLabels': ['Septal RF Ablation Group', 'Sham Procedure (No RF Ablation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Capital Medical University Affiliated Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Sir Run Run Shaw hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yongxin Su', 'role': 'CONTACT', 'email': 'suyongxin@sinusmedtech.com', 'phone': '+86 18121015668'}], 'overallOfficials': [{'name': 'Changshen Ma, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Medical University Affiliated Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data (IPD) for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SuZhou Sinus Medical Technologies Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}