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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septal RF Ablation Group | Experimental | Participants in this group will receive a transcatheter intramyocardial septal radiofrequency ablation under intracardiac echocardiography (ICE) guidance using the investigational device system. Standardized pharmacological therapy will be continued throughout the study period. |
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| Sham Procedure (No RF Ablation) | Sham Comparator | Participants in this group will undergo a sham procedure under ICE guidance. The catheter will be inserted but no ablation will be performed. Participants will continue standardized pharmacological therapy throughout the study period. After completion of the 6-month follow-up, participants in this arm may voluntarily choose to receive the investigational treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Intramyocardial Septal Radiofrequency Ablation System | Device | The device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE). |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Effectiveness Rate at 6 Months | Defined as either (1) a ≥50% reduction in resting LVOT gradient from baseline, or (2) resting LVOT gradient <30 mmHg. | 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting LVOT Gradient | Measured by echocardiography at baseline, 6 months, and 12 months | Baseline, 6 months, 12 months |
| Change in NYHA Functional Class | Proportion of patients with improvement of ≥1 NYHA class |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongxin Su | Contact | +86 18121015668 | suyongxin@sinusmedtech.com |
| Name | Affiliation | Role |
|---|---|---|
| Changshen Ma, Doctor | Capital Medical University Affiliated Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Affiliated Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
There is no plan to share individual participant data (IPD) for this study.
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Participants and outcomes assessors are blinded to group assignment until completion of the 6-month primary endpoint assessment.
| Baseline, 6 months, 12 months |
| Change in 6-Minute Walk Distance | Distance walked in 6 minutes, compared to baseline | Baseline, 6 months, 12 months |
| Change in 12-Item Short Form Health Survey (SF-12) Score | 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. | Baseline, 6 months, 12 months |
| Device Success Rate | Defined as successful completion of RF ablation per protocol | Day of procedure |
| Incidence of Adverse Events | All adverse events related to device or procedure | Through 12 months |
| Sir Run Run Shaw hospital | Recruiting | Hangzhou | Zhejiang | 310016 | China |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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