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
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)
• Septal thickness ≥15 mm
• Unsuitable for surgical myectomy or refusal of surgery
• Provided informed consent and agree to complete follow-up