NCT05854238

The Study for Evaluate of Safety and Efficacy of Vein of Marshall RF Ablation

A Multicenter, Open, Single Design, Researcher-led, Phase 1 Exploratory Study to Evaluate the Safety and Efficacy of Vein of Marshall RF Ablation Using TIRA(VA510 and Other 3 Types) in Patients With Persistent Atrial Fibrillation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Tau-MEDICAL Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the initial safety and effectiveness of an investigational medical device. Electrode catheter ablation of the Marshall vein is performed using TIRA, a clinical trial medical device for patients with persistent atrial fibrillation,

Detailed description

By analyzing the collected data, the initial safety and efficacy of the electrode catheter ablation effect of the clinical trial medical device is evaluated. After the clinical trial, the initial safety and efficacy of the electrode catheter ablation are evaluated by analyzing the changes in electrical signals before and after the procedure and by monitoring patients.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	TIRA-VoM	treat persistent atrial fibrillation * The ablation temperature range is 50-60℃ * About 2 minutes per ablation

Timeline

• Start date: 2023-08-03
• Primary completion: 2024-04-04
• Completion: 2025-04-07
• First posted: 2023-05-11
• Last updated: 2025-04-15

Locations

2 sites across 1 country: South Korea