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

SuZhou Sinus Medical Technologies

Status: Enrolling

Conditions: Hypertrophic Cardiomyopathy, Obstructive

Treatments: Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07006493

CRCT-001

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Asymptomatic or non-obstructive HCM
• Septal thickness ≥30 mm
• Mitral valve anatomy not suitable for ablation as judged by investigator
• High risk of sudden cardiac death (SCD) requiring ICD implantation
• Complete right bundle branch block at screening
• Infective endocarditis, myocarditis, atrial myxoma, or intracardiac thrombus
• Contraindication to transseptal access (e.g., septal patch)
• Mechanical valves or history of aortic valve replacement
• Severe heart failure with persistent symptoms and LVEF <40%
• Major cardiac events within 6 months (e.g., cardiac arrest, MI, heart failure hospitalization)
• Significant structural heart disease requiring surgery
• Prior septal reduction therapy or pacemaker implantation
• Constrictive pericarditis or significant congenital heart disease
• Bleeding disorders or contraindication to antithrombotic therapy
• Liver dysfunction (ALT/AST >3× ULN)
• Renal insufficiency (creatinine >2.0 mg/dL or on dialysis)
• Pregnant, breastfeeding, or planning pregnancy within 6 months post-op
• Life expectancy <12 months
• Participation in other investigational studies within 30 days or 5 half-lives
• Investigator determines poor compliance or unsuitability
• Contraindications to cardiac MRI (e.g., ICD, allergy to contrast, claustrophobia)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Septal RF Ablation Group

Experimental group

Description:

Participants in this group will receive a transcatheter intramyocardial septal radiofrequency ablation under intracardiac echocardiography (ICE) guidance using the investigational device system. Standardized pharmacological therapy will be continued throughout the study period.

Treatment:

Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System

Sham Procedure (No RF Ablation)

Sham Comparator group

Description:

Participants in this group will undergo a sham procedure under ICE guidance. The catheter will be inserted but no ablation will be performed. Participants will continue standardized pharmacological therapy throughout the study period. After completion of the 6-month follow-up, participants in this arm may voluntarily choose to receive the investigational treatment.

Treatment:

Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System