Clinical trial NCT07006493: REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertrophic Cardiomyopathy, Obstructive
Lead sponsor: SuZhou Sinus Medical Technologies Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-05
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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)

Primary outcomes:
measure: Treatment Effectiveness Rate at 6 Months
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Change in Resting LVOT Gradient
timeFrame: Baseline, 6 months, 12 months
measure: Change in NYHA Functional Class
timeFrame: Baseline, 6 months, 12 months
measure: Change in 6-Minute Walk Distance
timeFrame: Baseline, 6 months, 12 months
measure: Change in 12-Item Short Form Health Survey (SF-12) Score
timeFrame: Baseline, 6 months, 12 months
measure: Device Success Rate
timeFrame: Day of procedure
measure: Incidence of Adverse Events
timeFrame: Through 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Capital Medical University Affiliated Beijing Anzhen Hospital
name: Changshen Ma, Doctor
role: PRINCIPAL_INVESTIGATOR
References: