REFINE-HCM: A Multicenter Randomized Trial of Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
- Conditions
- Hypertrophic Cardiomyopathy, Obstructive
- Registration Number
- NCT07006493
- Lead Sponsor
- SuZhou Sinus Medical Technologies Co.,Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 124
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Treatment Effectiveness Rate at 6 Months 6 months post-procedure Defined as either (1) a ≥50% reduction in resting LVOT gradient from baseline, or (2) resting LVOT gradient \<30 mmHg.
- Secondary Outcome Measures
Name Time Method Change in Resting LVOT Gradient Baseline, 6 months, 12 months Measured by echocardiography at baseline, 6 months, and 12 months
Change in NYHA Functional Class Baseline, 6 months, 12 months Proportion of patients with improvement of ≥1 NYHA class
Change in 6-Minute Walk Distance Baseline, 6 months, 12 months Distance walked in 6 minutes, compared to baseline
Change in SF-12 Health Survey Score Baseline, 6 months, 12 months Physical and mental component summary scores
Device Success Rate Day of procedure Defined as successful completion of RF ablation per protocol
Incidence of Adverse Events Through 12 months All adverse events related to device or procedure