REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcatheter Intramyocardial Septal Radiofrequency Ablation System.
- Who it may be relevant to
- Registry conditions: Hypertrophic Cardiomyopathy, Obstructive. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Device Transcatheter Intramyocardial Septal Radiofrequency Ablation System
The device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE).
Primary outcome measures
- Treatment Effectiveness Rate at 6 Months [Time frame: 6 months post-procedure]
Secondary outcome measures (6)
- Change in Resting LVOT Gradient [Time frame: Baseline, 6 months, 12 months]
- Change in NYHA Functional Class [Time frame: Baseline, 6 months, 12 months]
- Change in 6-Minute Walk Distance [Time frame: Baseline, 6 months, 12 months]
- Change in 12-Item Short Form Health Survey (SF-12) Score [Time frame: Baseline, 6 months, 12 months]
- Device Success Rate [Time frame: Day of procedure]
- Incidence of Adverse Events [Time frame: Through 12 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Capital Medical University Affiliated Beijing Anzhen Hospital — Beijing
- Sir Run Run Shaw hospital — Hangzhou
Identifiers
NCT: NCT07006493 · CRCT-001