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

NCT ID: NCT07006493

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-20
• Study Completion Date: 2027-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Septal RF Ablation Group

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.

Group Type: EXPERIMENTAL

Transcatheter Intramyocardial Septal Radiofrequency Ablation System

Intervention Type: DEVICE

The device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE).

Sham Procedure (No RF Ablation)

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.

Group Type: SHAM_COMPARATOR

Transcatheter Intramyocardial Septal Radiofrequency Ablation System

Intervention Type: DEVICE

The device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SuZhou Sinus Medical Technologies Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Changshen Ma, Doctor

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University Affiliated Beijing Anzhen Hospital

Locations

Capital Medical University Affiliated Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Sir Run Run Shaw hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongxin Su

Role: CONTACT

suyongxin@sinusmedtech.com

+86 18121015668

Other Identifiers

CRCT-001

Identifier Type: -

Identifier Source: org_study_id