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NCT05731882

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

Status unknown NA Last updated 17 January 2024
What this trial tests

NA trial testing E-SeaLA, CardioPulse PFA system in Nonvalvular Atrial Fibrillation in 10 participants. Status unknown.

Timeline
17 July 2022
Primary endpoint
1 June 2024
1 August 2024

Quick facts

Lead sponsorHangzhou Dinova EP Technology Co., Ltd
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date17 July 2022
Primary completion1 June 2024
Estimated completion1 August 2024
Sites3 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Hangzhou Dinova EP Technology Co., Ltd — full company profile →

Who can join

Adults 18 to 80, any sex, with Nonvalvular Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Simultaneous Pulsed Field Ablation and Mechanical Closure of Left Atrial Appendage Using a Novel Device.
    Tang M, Wang X, Reddy VY. · · 2023 · cited 3× · PMID 37790777 · DOI 10.1016/j.jaccas.2023.101963
  2. Combined Catheter Ablation and Left Atrial Appendage Occlusion in Atrial Fibrillation: From Data to Clinical Reality.
    Dimitriadis K, Adamopoulou E, Pyrpyris N, Iliakis P, et al · · 2026 · cited 1× · PMID 40237856 · DOI 10.1007/s10557-025-07685-2

Verify or expand the search:

Other recruiting trials for Nonvalvular Atrial Fibrillation

Currently open trials in the same condition.

Other Hangzhou Dinova EP Technology Co., Ltd trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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