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.
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)
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