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REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy

RecruitingNAAges 18 Years - 80 YearsAllSuZhou Sinus Medical Technologies Co.,Ltd
NCT07006493 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 to 80 years, regardless of sex * Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) * Presence of significant symptoms (e.g., dyspnea, chest pain, fatigue, palpitations, syncope) * NYHA class II or higher with LVOTG ≥50 mmHg at rest or provoked (assessed by echocardiography) * Septal thickness ≥15 mm * Unsuitable for surgical myectomy or refusal of surgery * Provided informed consent and agree to complete follow-up Exclusion Criteria: * Asymptomatic or non-obstructive HCM * Septal thickness ≥30 mm * Mitral valve anatomy not suitable for ablation as judged by investigator * High risk of sudden cardiac death (SCD) requiring ICD implantation * Complete right bundle branch block at screening * Infective endocarditis, myocarditis, atrial myxoma, or intracardiac thrombus * Contraindication to transseptal access (e.g., septal patch) * Mechanical valves or history of aortic valve replacement * Severe heart failure with persistent symptoms and LVEF \<40% * Major cardiac events within 6 months (e.g., cardiac arrest, MI, heart failure hospitalization) * Significant structural heart disease requiring surgery * Prior septal reduction therapy or pacemaker implantation * Constrictive pericarditis or significant congenital heart disease * Bleeding disorders or contraindication to antithrombotic therapy * Liver dysfunction (ALT/AST \>3× ULN) * Renal insufficiency (creatinine \>2.0 mg/dL or on dialysis) * Pregnant, breastfeeding, or planning pregnancy within 6 months post-op * Life expectancy \<12 months * Participation in other investigational studies within 30 days or 5 half-lives * Investigator determines poor compliance or unsuitability * Contraindications to cardiac MRI (e.g., ICD, allergy to contrast, claustrophobia)
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What it tests

  • Transcatheter Intramyocardial Septal Radiofrequency Ablation System
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Where

2 sites
Capital Medical University Affiliated Beijing Anzhen Hospital
Beijing, China
Sir Run Run Shaw hospital
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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