Actively Recruiting
Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2022-12-19
579
Participants Needed
5
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Able to understand the study purpose and willing to provide informed consent
- Indicated for left atrial appendage closure
- Non-valvular atrial fibrillation with previous AF-related embolic event
- Meet at least one of: HAS-BLED score 23, unsuitable for long-term oral anticoagulants, poor compliance with oral anticoagulants, or CHA2DS2-VASc score 2
You will not qualify if you...
- Valvular atrial fibrillation due to moderate to severe mitral stenosis or mechanical valve replacement
- Initial or reversible atrial fibrillation with a clear cause
- Presence of adherent thrombus in left atrium or left ventricular aneurysm thrombus
- ST elevation myocardial infarction within the past 3 months
- Grade-IV cardiac function (NYHA classification)
- Allergy or contraindication to nitinol, aspirin, clopidogrel, heparin, or other anticoagulants
- Pregnant or planning pregnancy during the study
- Participation in another ongoing drug or device clinical trial
- New stroke or transient ischemic attack within 30 days, or major bleeding within 14 days
- Contraindication to LAA closure or deemed unsuitable by investigator
- History of definite thromboembolic event
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000
Actively Recruiting
2
Shanghai Songjiang District Central Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
3
Sichuan Mianyang 404 Hospital
Mianyang, Sichuan, China, 621000
Actively Recruiting
4
The first Affiliated Hospital of WMU
Wenzhou, Zhejiang, China, 325600
Actively Recruiting
5
The Second Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, China, 325600
Actively Recruiting
Research Team
C
Chenyang Jiang, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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