NCT06368037

Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy

To Evaluate the Safety and Feasibility of the DragonFire Transcatheter Radiofrequency Myocardial Ablation System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hangzhou Valgen Medtech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively.

Conditions

• Obstructive Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	DragonFire Transcatheter Myocardial Radiofrequency Ablation System	The patients with hypertrophic obstructive cardiomyopathy were treated with a transcatheter myocardial radiofrequency ablation system and its guiding system under the guidance of echocardiography

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: China