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Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated December 19, 2022 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Nov 2023 to Nov 2025
    • Study sites: 0 to 5
    • Study completion date: Feb 2024 to Nov 2027
    • Start date changed from estimate of Nov 2020 to Nov 12, 2020
    • Secondary endpoints revised (7)
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. 579 patients with valvular AF complicated with previous AF-related embolic events (including ischemic stroke, TIA and systemic embolism) were enrolled at about 20 study sites nationwide. The baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.
Trial Details
NCT Number NCT04559243
Lead Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions
(from sponsor)		 Non-valvular Atrial Fibrillation, Embolic Stroke
Related terms Embolic Stroke
Enrollment 579 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov