Evaluation of the Safety and Efficacy of a Novel SeaLA™ Left Atrial Appendage Occluder (NCT05911685) | Clinical Trial Compass
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Evaluation of the Safety and Efficacy of a Novel SeaLA™ Left Atrial Appendage Occluder
China163 participantsStarted 2019-03-26
Plain-language summary
This study adapted a prospective, multicenter single-group objective performance criteria design. A total of 163 patients with non-valvular atrial fibrillation were enrolled in the clinical trial，follow up were scheduled in 7 days, 45 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5years after procedure.
Who can participate
Age range
18 Years – 80 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
. Patients with nonvalvular paroxysmal, persistent or permanent atrial fibrillation;
. Subject is not suitable for long-term treatment with anticoagulant;
. Subjects are suitable for dual antiplatelet therapy for 3 months and complete follow-up;
Exclusion criteria
. Patients with atrial fibrillation caused by rheumatic heart valve disease, degenerative heart valve disease, or congenital heart valve disease;
. Patients after heart transplantation;
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.
. Unstable angina or recent myocardial infarction \< 3 months;
. Cardiac function IV (NYHA grade);
. Subject requires atrial fibrillation catheter ablation surgery within 30 days of LAA occlusion device implantation;
. Excludes the case of atrial fibrillation catheter ablation and LAA closure in the same surgery (if atrial fibrillation catheter ablation and LAA closure are operated on the same operation, it is recommended to have catheter ablation before closure);
. Subject has an electrical cardioversion plan within 30 days of LAA occlusion device implantation;