Tests a heart-tissue radiofrequency ablation device in adults with obstructive hypertrophic cardiomyopathy
Tests a catheter ablation device on the heart septum in adults with thickened heart muscle.
Plain-language title generated from the registry record
Registry title: REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
Key facts
- Where
- Beijing and Hangzhou, ChinaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07006493, who can take part
Where in China
- Capital Medical University Affiliated Beijing Anzhen HospitalBeijing, ChinaTaking people
- Sir Run Run Shaw HospitalHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SuZhou Sinus Medical Technologies Co.,Ltd
- Trial code
- NCT07006493
- Record updated
- 15 December 2025
- Original description
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.Read full original descriptionShow less
A Prospective, Multicenter, Randomized, Parallel-Controlled Superiority Study Evaluating the Efficacy and Safety of a Transcatheter Intramyocardial Septal Radiofrequency Ablation System in Patients With Obstructive Hypertrophic Cardiomyopathy
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.
Inclusion: 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: Prior septal reduction therapy or pacemaker implantation; High risk of sudden cardiac death (SCD) requiring ICD implantation; Mechanical valves or history of aortic valve replacement; Major cardiac events within 6 months (e.g., cardiac arrest, MI, heart failure hospitalization); Significant structural heart disease requiring surgery; Constrictive pericarditis or significant congenital heart disease; Bleeding disorders or contraindication to antithrombotic therapy; Contraindications to cardiac MRI (e.g., ICD, allergy to contrast, claustrophobia); Severe heart failure with persistent symptoms and LVEF <40%; Liver dysfunction (ALT/AST >3× ULN); Renal insufficiency (creatinine >2.0 mg/dL or on dialysis); Asymptomatic or non-obstructive HCM; Septal thickness ≥30 mm; Mitral valve anatomy not suitable for ablation as judged by investigator; Complete right bundle branch block at screening; Infective endocarditis, myocarditis, atrial myxoma, or intracardiac thrombus; Contraindication to transseptal access (e.g., septal patch); 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.