Recruiting
NA
INTERVENTIONAL
NCT05731882
First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
E-SeaLA, CardioPulse PFA system
Type:
DEVICE
Description:
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.
Primary Outcomes
Measure:
Technical success rate
TimeFrame:
immediately after the procedure
Description:
Technical success means that the pulmonary vein and left atrial appendage(LAA) remain electrical isolation 20 minutes after ablation, and the per-device leaks≤ 3 mm after E-SeaLA LAA pulsed field ablation(PFA) occluder implantation.
Measure:
The incidence of major adverse events (MAEs) related to devices or procedures 3 months after procedure
TimeFrame:
within 3 months after procedure
Description:
MAE includes death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve palsy, systemic embolism, pericarditis, pericardial effusion/cardiac tamponade, atrial esophageal fistula, severe vascular access complications, device migration, and device embolization.
Trial Information
NCT ID
NCT05731882
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Hangzhou Dinova EP Technology Co., Ltd
Last Updated
December 15, 2025