NCT07006493 REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
| NCT ID | NCT07006493 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SuZhou Sinus Medical Technologies Co.,Ltd |
| Condition | Hypertrophic Cardiomyopathy, Obstructive |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2025-07-20 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2025-07-20 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Changshen Ma, Doctor
PRINCIPAL INVESTIGATOR
Capital Medical University Affiliated Beijing Anzhen Hospital
Frequently Asked Questions
Who can join the NCT07006493 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hypertrophic Cardiomyopathy, Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07006493 currently recruiting?
Yes, NCT07006493 is actively recruiting participants. Contact the research team at suyongxin@sinusmedtech.com for enrollment information.
Where is the NCT07006493 trial being conducted?
This trial is being conducted at Beijing, China, Hangzhou, China.
Who is sponsoring the NCT07006493 clinical trial?
NCT07006493 is sponsored by SuZhou Sinus Medical Technologies Co.,Ltd. The principal investigator is Changshen Ma, Doctor at Capital Medical University Affiliated Beijing Anzhen Hospital. The trial plans to enroll 124 participants.