Follow-up study of a heart device closing the left atrial appendage in atrial fibrillation
Studies a device that closes the heart's left atrial appendage in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
Key facts
- Where
- Jinan, Mianyang, Shanghai, and Wenzhou, ChinaSee the 5 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with atrial fibrillation not caused by a heart valve problem, who have already had a clot-related event such as a stroke. It tests a device that closes part of the heart.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Atrial fibrillation not caused by a heart valve problem, with an earlier clot-related event linked to the atrial fibrillation.
Main reasons for not taking part
- Heart valve atrial fibrillation (after moderate to severe mitral stenosis or mechanical valve replacement)
- Clot in the left atrium or in a left ventricular aneurysm
- Heart attack (ST elevation) within 3 months
- Pregnant or planning pregnancy during the study
- New stroke or TIA within 30 days, or major bleeding within 14 days
Read by machine on 9 November 2026.
Where in China
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- Sichuan Mianyang 404 HospitalMianyang, ChinaTaking people
- Shanghai Songjiang District Central HospitalShanghai, ChinaTaking people
- The First Affiliated Hospital of WMUWenzhou, ChinaTaking people
- The Second Affiliated Hospital and Yuying Children's Hospital of WMUWenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Trial code
- NCT04559243
- Record updated
- 19 December 2022
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥ 18 years, male or female; Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (ICF), and are willing to complete the follow-up as required by the protocol; Indications for left atrial appendage closure; Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions; 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.
Exclusion: Participation in another drug or medical device clinical trial or study that has not been completed; ST elevation myocardial infarction, ≤ 3 months; Grade-IV of Cardiac Function (NYHA); Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants; Experience new stroke or TI within 30 days or major bleeding events within 14 days; Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement); Initial AF, reversible AF with clear cause; Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus; Pregnant or with plan of pregnancy during the study; Contraindication to LAA closure or deemed unsuitable for study participation by the investigator; Had a definite thromboembolic event.