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RECRUITING
NCT07006493
NA

REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy

Sponsor: SuZhou Sinus Medical Technologies Co.,Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-07-20

Completion Date

2027-12-30

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DEVICE

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).

Locations (2)

Capital Medical University Affiliated Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Sir Run Run Shaw hospital

Hangzhou, Zhejiang, China