Hypertrophic Cardiomyopathy, Obstructive
Conditions
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.
Interventions
DEVICETranscatheter 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).
Sponsors
SuZhou Sinus Medical Technologies Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcomes assessors are blinded to group assignment until completion of the 6-month primary endpoint assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Effectiveness Rate at 6 Months | 6 months post-procedure | Defined as either (1) a ≥50% reduction in resting LVOT gradient from baseline, or (2) resting LVOT gradient \<30 mmHg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in NYHA Functional Class | Baseline, 6 months, 12 months | Proportion of patients with improvement of ≥1 NYHA class |
| Change in 6-Minute Walk Distance | Baseline, 6 months, 12 months | Distance walked in 6 minutes, compared to baseline |
| Change in Resting LVOT Gradient | Baseline, 6 months, 12 months | Measured by echocardiography at baseline, 6 months, and 12 months |
| Device Success Rate | Day of procedure | Defined as successful completion of RF ablation per protocol |
| Incidence of Adverse Events | Through 12 months | All adverse events related to device or procedure |
| Change in 12-Item Short Form Health Survey (SF-12) Score | Baseline, 6 months, 12 months | The SF-12 Health Survey includes two components: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better health status. |
Countries
China
Contacts
Primary ContactYongxin Su
Outcome results
None listed