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
Parallel
Transcatheter Intramyocardial Septal Radiofrequency Ablation System
DeviceThe device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE).
Treatment Effectiveness Rate at 6 Months
Defined as either (1) a ≥50% reduction in resting LVOT gradient from baseline, or (2) resting LVOT gradient \<30 mmHg.
Change in Resting LVOT Gradient
Measured by echocardiography at baseline, 6 months, and 12 months
Change in NYHA Functional Class
Proportion of patients with improvement of ≥1 NYHA class
Change in 6-Minute Walk Distance
Distance walked in 6 minutes, compared to baseline
Change in 12-Item Short Form Health Survey (SF-12) Score
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.
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