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
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)
Original Eligibility Criteria
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Treatments Being Tested
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).