Catheter-delivered radiofrequency treatment of the thickened heart septum for obstructive hypertrophic cardiomyopathy
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 trial will test whether catheter-delivered radiofrequency ablation of the thickened septum can lower the outflow gradient and improve symptoms in adults with obstructive hypertrophic cardiomyopathy who cannot or will not have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | SuZhou Sinus Medical Technologies Co.,Ltd Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT07006493 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, randomized, parallel-controlled, superiority trial comparing active transcatheter intramyocardial septal radiofrequency ablation guided by intracardiac echocardiography to a sham procedure with continued standard medical therapy. Eligible participants are randomized 2:1 to receive active ablation or sham, with follow-up and functional assessment through 6 months. The primary effectiveness 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. Key eligibility features include symptomatic oHCM with NYHA class II or higher, LVOT gradient ≥50 mmHg (resting or provoked), and septal thickness ≥15 mm but <30 mm, in patients unsuitable for or refusing surgical myectomy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–80 with symptomatic obstructive HCM (NYHA II or higher) with an LVOT gradient ≥50 mmHg and septal thickness ≥15 mm who are unsuitable for or refuse surgical myectomy.
Not a fit: Patients who are asymptomatic or have non-obstructive HCM, extremely thick septa (≥30 mm), anatomy unsuitable for the procedure, very high arrhythmic risk requiring ICD, or severe advanced heart failure are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the procedure could offer a less invasive option to reduce LV outflow obstruction and improve symptoms for patients who are not candidates for or decline surgery.
How similar studies have performed: Related catheter-based approaches such as alcohol septal ablation and small case series of septal radiofrequency ablation have shown symptomatic and gradient improvements, but randomized sham-controlled evidence for intramyocardial radiofrequency ablation is limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Capital Medical University Affiliated Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Sir Run Run Shaw hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Changshen Ma, Doctor — Capital Medical University Affiliated Beijing Anzhen Hospital
- Study coordinator: Yongxin Su
- Email: suyongxin@sinusmedtech.com
- Phone: +86 18121015668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.