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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
The device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE).
Capital Medical University Affiliated Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
RECRUITINGSir Run Run Shaw hospital
Hangzhou, Zhejiang, China
RECRUITINGTreatment 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.
Time frame: 6 months post-procedure
Change in Resting LVOT Gradient
Measured by echocardiography at baseline, 6 months, and 12 months
Time frame: Baseline, 6 months, 12 months
Change in NYHA Functional Class
Proportion of patients with improvement of ≥1 NYHA class
Time frame: Baseline, 6 months, 12 months
Change in 6-Minute Walk Distance
Distance walked in 6 minutes, compared to baseline
Time frame: Baseline, 6 months, 12 months
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.
Time frame: Baseline, 6 months, 12 months
Device Success Rate
Defined as successful completion of RF ablation per protocol
Time frame: Day of procedure
Incidence of Adverse Events
All adverse events related to device or procedure
Time frame: Through 12 months
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