Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
Condition(s) studied
Investigational drug(s) / intervention(s)
Transthoracic Echocardiography: After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation — 12 months
Ischemic stroke, systemic embolism, and cardiac death events - Incidence of major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of ≥ 2 units of red blood cells) at 12 months after operation — 12 months
Bleeding events
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | Recruiting |
| Shanghai Songjiang District Central Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Sichuan Mianyang 404 Hospital | Mianyang | Sichuan | Recruiting |
| The first Affiliated Hospital of WMU | Wenzhou | Zhejiang | Recruiting |
| The Second Affiliated Hospital and Yuying Children's Hospital of WMU | Wenzhou | Zhejiang | Recruiting |
More Lifetech Scientific (Shenzhen) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04559243 on ClinicalTrials.gov ↗ ← All trials in China