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

Summary

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.

Eligibility

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)

Conditions2

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