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
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.