Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events (NCT04559243) | Clinical Trial Compass
RecruitingNot Applicable
Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
China579 participantsStarted 2020-11-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. HAS-BLED bleeding risk score ≥ 3 points;
. Not suitable for long-term oral anticoagulant therapy;
. Poor compliance with oral anticoagulants;
. CHA2DS2-VASc score ≧ 2 points;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation
Timeframe: 12 months
2
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