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

NCT07006493 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

  • Hypertrophic Cardiomyopathy, Obstructive

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).

Sponsors & Collaborators

  • SuZhou Sinus Medical Technologies Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Changshen Ma, Doctor · Capital Medical University Affiliated Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-20
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07006493 on ClinicalTrials.gov