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

NCT07006493 | Recruiting DMC

• 1 other identifier: CRCT-001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Treatment 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.

  6 months post-procedure

Secondary Outcomes (6)

• Change in Resting LVOT Gradient

  Baseline, 6 months, 12 months

• Change in NYHA Functional Class

  Baseline, 6 months, 12 months

• Change in 6-Minute Walk Distance

  Baseline, 6 months, 12 months

• Change in 12-Item Short Form Health Survey (SF-12) Score

  Baseline, 6 months, 12 months

• Device Success Rate

  Day of procedure

Study Arms (2)

Septal RF Ablation Group

EXPERIMENTAL

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.

Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System

Sham Procedure (No RF Ablation)

SHAM COMPARATOR

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.

Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System

Interventions

Transcatheter Intramyocardial Septal Radiofrequency Ablation System DEVICE

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

Septal RF Ablation Group; Sham Procedure (No RF Ablation)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• SuZhou Sinus Medical Technologies Co.,Ltd: lead

Study Sites (2)

Capital Medical University Affiliated Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Sir Run Run Shaw hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Changshen Ma, Doctor

  Capital Medical University Affiliated Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongxin Su

CONTACT

+86 18121015668; suyongxin@sinusmedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessors are blinded to group assignment until completion of the 6-month primary endpoint assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)