Actively Recruiting
REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
Led by SuZhou Sinus Medical Technologies Co.,Ltd · Updated on 2025-12-15
124
Participants Needed
2
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, regardless of sex
- Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM)
- Presence of significant symptoms such as dyspnea, chest pain, fatigue, palpitations, or syncope
- New York Heart Association (NYHA) class II or higher with left ventricular outflow tract gradient (LVOTG) ≥50 mmHg at rest or with provocation
- Septal thickness of 15 mm or more
- Unsuitable for surgical myectomy or refusal of surgery
- Provided informed consent and agree to complete follow-up
You will not qualify if you...
- Asymptomatic or non-obstructive hypertrophic cardiomyopathy
- Septal thickness greater than 30 mm
- Mitral valve anatomy unsuitable for ablation as judged by investigator
- High risk of sudden cardiac death requiring implantable cardioverter defibrillator (ICD)
- Complete right bundle branch block at screening
- Infective endocarditis, myocarditis, atrial myxoma, or intracardiac thrombus
- Contraindication to transseptal access such as septal patch
- Presence of mechanical valves or history of aortic valve replacement
- Severe heart failure with persistent symptoms and left ventricular ejection fraction below 40%
- Major cardiac events within 6 months such as cardiac arrest, myocardial infarction, or 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 with ALT/AST more than 3 times upper limit of normal
- Renal insufficiency with creatinine above 2.0 mg/dL or on dialysis
- Pregnant, breastfeeding, or planning pregnancy within 6 months post-operation
- Life expectancy less than 12 months
- Participation in other investigational studies within 30 days or 5 half-lives
- Investigator determines poor compliance or unsuitability
- Contraindications to cardiac MRI such as ICD, allergy to contrast, or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Capital Medical University Affiliated Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
Sir Run Run Shaw hospital
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
Research Team
Y
Yongxin Su
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here