Catheter-delivered radiofrequency treatment of the thickened heart septum for obstructive hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry to assess patient characteristics and outcomes in obstructive hypertrophic cardiomyopathy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.