Actively Recruiting
Percutaneous Left Atrial Appendage Closure for Secondary Prevention of Atrial Fibrillation-related Embolic Events in Patients With Non-valvular Atrial Fibrillation
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2022-12-19
579
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a device called the LAmbre2 Left Atrial Appendage Occluder System for patients with non-valvular atrial fibrillation (AF) who have had previous embolic events such as ischemic stroke, transient ischemic attack (TIA), or systemic embolism. This multicenter, prospective, non-interventional study involves 579 patients across about 20 sites and aims to assess whether this procedure can serve as secondary prevention for AF-related embolic events. The study involves observing patients undergoing percutaneous left atrial appendage closure using the LAmbre2 device. Data is collected on baseline health, the operation process, and follow-up information at multiple time points: before discharge or 7 months after the procedure, then at 1, 3, 6, 12, and 24 months after the operation. The only intervention mentioned is transthoracic echocardiography, which is used to collect data during eight follow-up visits. Participants will have regular hospital visits for assessments including echocardiography and other clinical evaluations at scheduled intervals up to 24 months after the procedure. Researchers will monitor the incidence of new ischemic strokes, systemic embolisms, cardiac deaths, major bleeding events, surgery success rates, and any complications related to the procedure or device. Safety and effectiveness will be tracked through these measures to better understand outcomes after left atrial appendage closure in this patient group.
CONDITIONS
Brief 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, any gender
- Able to understand the study purpose and willing to sign informed consent
- Suitable for left atrial appendage closure procedure
- Diagnosed with non-valvular atrial fibrillation and previous embolic events
- Meet at least one of the following: HAS-BLED bleeding risk score of 3 or higher; not suitable for long-term oral anticoagulant therapy; poor compliance with oral anticoagulants; CHA2DS2-VASc score of 2 or higher
You will not qualify if you...
- Valvular atrial fibrillation after moderate to severe mitral stenosis or mechanical valve replacement
- Initial or reversible atrial fibrillation with a clear cause
- Presence of thrombus in left atrium or left ventricular aneurysm
- ST elevation myocardial infarction within 3 months
- Severe (Grade IV) cardiac function (NYHA classification)
- Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, or other anticoagulants
- Pregnant or planning pregnancy during the study
- Participation in another ongoing drug or medical device trial
- New stroke or transient ischemic attack within 30 days or major bleeding within 14 days
- Contraindication to left atrial appendage closure or deemed unsuitable by investigator
- History of definite thromboembolic event
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days or until discharge
Participants undergo percutaneous left atrial appendage closure to prevent embolic events.
1 surgical procedure and hospital stay
Duration - Up to 24 months
Participants return for follow-up visits to monitor recovery and collect diagnostic test data after surgery.
8 visits (in-person) for transthoracic echocardiography and assessments
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
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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