NCT05731882

First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder

First in Man Study to Evaluate Safety and Efficacy of Left Atrial Appendage Pulsed Field Ablation Occluder for Simultaneous Pulsed Field Ablation and Mechanical Closure of the Left Atrial Appendage in Patients With Nonvalvular Atrial Fibrillation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hangzhou Dinova EP Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this study aims to initially verify the safety and efficacy of the device.

Conditions

• Nonvalvular Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	E-SeaLA, CardioPulse PFA system	First, pulmonary vein isolation(PVI) was performed with the novel hex spline PFA ablation catheter( CardioPulseTM PFA system, Hangzhou Dinova EP Technology Co., Ltd), then, pulsed field ablation and mechanical closure of the left atrial appendage were achieved by E-SeaLATM(Hangzhou Dinova EP Technology Co., Ltd) implantation.

Timeline

• Start date: 2022-07-17
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2023-02-16
• Last updated: 2024-01-17

Locations

3 sites across 1 country: China