NCT04559243

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

A Prospective, Multicenter Clinical Study of Percutaneous Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events in Patients With Atrial Fibrillation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 579 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study Population Patients with non-valvular atrial fibrillation and previous AF-related embolic events Purpose To assess the feasibility and safety of percutaneous LAA closure as secondary prevention for patients with non-valvular atrial fibrillation (NVAF) and previous atrial fibrillation (AF) related embolic events (including ischemic stroke, transient ischemic attack (TIA), and systemic embolism).

Conditions

• Non-valvular Atrial Fibrillation
• Embolic Stroke

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transthoracic Echocardiography	After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.

Timeline

• Start date: 2020-11-12
• Primary completion: 2025-11-01
• Completion: 2027-11-01
• First posted: 2020-09-22
• Last updated: 2022-12-19

Locations

5 sites across 1 country: China