CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title: Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation

Status Not yet recruiting

Clinical Trial Summary

This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.

Clinical Trial Description

This study is a prospective, multicenter, single arm, non-randomized, feasibility study. Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box. All subjects will return to the hospital between 60-120 days post-surgical ablation procedure to undergo a cardiac electrophysiology study with electroanatomical mapping to assess electrical isolation of the pulmonary veins and left atrial posterior wall ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Surgery

• NCT number: NCT06355063
• Study type: Interventional
• Source: Pulse Biosciences, Inc.
• Contact: William A. Knape
• Phone: +1 (919) 757-2033
• Email: bknape@pulsebiosciences.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Completion date: October 31, 2025