NCT07006493Recruiting
REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation 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
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 27 May 2025
- Start date
- 20 Jul 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- SuZhou Sinus Medical Technologies Co.,Ltd
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07006493
What you commit to
- Study type: Interventional
- Planned participants: 124
- From 20 Jul 2025 to the primary completion date, 30 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior septal reduction therapy or pacemaker implantation
Other illness
- 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)
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Capital Medical University Affiliated Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.