NCT06277960

Septal Ablation for Obstructive HCM

A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Safety and Effectiveness of Percutaneous Intramyocardial Septal Radiofrequency Ablation System in the Treatment of Hypertrophic Obstructive Cardiomyopathy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: SuZhou Sinus Medical Technologies Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited. Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches. The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy.

Conditions

• Hypertrophic Obstructive Cardiomyopathy (HOCM)

Interventions

Type	Name	Description
DEVICE	percutaneous intramyocardial septal radiofrequency ablation system	The device is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum.

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2024-02-26
• Last updated: 2025-05-30

Locations

1 site across 1 country: China