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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form and agree to complete follow-up Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

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).

Locations (2)

Capital Medical University Affiliated Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Sir Run Run Shaw hospital
Hangzhou, Zhejiang, China