NCT05770921

Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

An Exploratory Study of Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter Guided by Columbus 3D EP Navigation System in the Ablation Treatment of Paroxysmal Supraventricular Tachycardia（PSVT）

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Ningbo No. 1 Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia.

Detailed description

The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following the last index PFA application with the investigational device

Conditions

• Paroxysmal Supraventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter	All subjects will be ablated using the Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the management of their Paroxysmal Supraventricular Tachycardia

Timeline

• Start date: 2022-10-11
• Primary completion: 2023-02-01
• Completion: 2023-07-13
• First posted: 2023-03-16
• Last updated: 2024-01-03

Locations

1 site across 1 country: China