LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke
NCT ID: NCT04429646
Last Updated: 2022-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
236 participants
INTERVENTIONAL
2019-04-20
2021-06-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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LAMax left atrial appendage occluder
Intervention device, LAMax left atrial appendage closure system
Percutaneous left atrial appendage closure-LAMax
Interventional device, LAMax left atrial appendage closure system
Watchman (control)
Intervention device, Watchman® LAA Closure Device
Percutaneous left atrial appendage closure-Watchman
Interventional device, Watchman® LAA Closure Device
Interventions
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Percutaneous left atrial appendage closure-LAMax
Interventional device, LAMax left atrial appendage closure system
Percutaneous left atrial appendage closure-Watchman
Interventional device, Watchman® LAA Closure Device
Eligibility Criteria
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Inclusion Criteria
* There is one of the following: (1) Not suitable for long-term standard anticoagulation treatment; (2) On the basis of long-term standardized anticoagulant therapy with warfarin, stroke or embolism still occurred; (3) HAS-BLED ≥ 3.
* Provide written informed consent and agree to comply with required follow-ups.
Exclusion Criteria
2. . Those who need selective cardiac surgery;
3. . Heart failure NYHA grade IV;
4. . AF caused by rheumatic valvular disease, degenerative valvular disease, congenital valvular disease, severe mitral stenosis, aortic stenosis, or other valvular diseases;
5. . The early onset of AF and paroxysmal AF with definite causes, such as secondary to coronary artery bypass grafting (CABG), hyperthyroidism;
6. . Patients with symptomatic carotid artery disease (such as carotid stenosis \> 50%);
7. . Patients with acute myocardial infarction, unstable angina, or recent myocardial infarction \< 3 months;
8. . Stroke or TIA within 30 days;
9. . Bleeding disease, coagulation-related diseases, and active peptic ulcer;
10. . Active endocarditis, vegetations, or other infections causing bacteremia or sepsis;
11. . Conditions may lead to difficulty in testing or significantly shorten the life expectancy of patients (\< 1 year);
12. . Pregnant, lactating or planned pregnancy during the trial;
13. . Patients who have not reached the end of other clinical trials of drug or device;
14. . Hematological abnormality (WBC \< 3 × 109 / L, HB \< 90g / L, or platelet count \< 50 × 109 / L or \> 700 × 109 / L));
15. . Renal insufficiency (creatinine \> 3.0mg/dl or 265.2umoi / L), and / or advanced renal diseases requiring dialysis;
16. . Severe liver dysfunction (AST / ALT is 5 times higher than the upper limit of normal value, or total bilirubin is 2 times higher than the upper limit of normal value);
17. . The investigator believes that the patient is not suitable to participate in the clinical trial.
18. . Left atrial appendage has been removed, post heart transplantation, post atrial septal repair, or post occluder implantation;
19. . Radiofrequency ablation in 30 days before and after the implantation of LAA occluder;
20. . Cardioversion within 30 days after the implantation of LAA occluder;
21. . Post prosthetic heart valve replacement;
22. . Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel, contrast agent, heparin and other anticoagulants, etc;
23. . Patients who have placed other instruments in the cardiovascular cavity and are unable to place the LAA occluder;
24. . LVEF（left ventricular ejection fraction ）\<35%；
25. . Clear thrombus is found in the heart before device implantation;
26. . TEE examination: refer to Watchman LAAC requirement to measure the orifice diameter of LAA, the maximum diameter is less than 17 mm, or more than 31 mm;
27. . Patent foramen ovale with high risk;
28. . mitral stenosis with a valve area ≤ 2 cm2;
29. . left atrial diameter \> 65mm, or pericardial effusion more than a small amount, the depth of local effusion \> 10 mm;
30. . Contraindications to X-ray, or not suitable for TEE examination.
18 Years
ALL
No
Sponsors
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The Third Medical Center, Chinese People's Liberation Army General Hospital
UNKNOWN
The Second Affiliated Hospital of Chongqing Medical University
OTHER
Ganzhou Municipal Hospital
UNKNOWN
First Affiliated Hospital of Guangxi Medical University
OTHER
The Second Hospital of Hebei Medical University
OTHER
The First Hospital of Jilin University
OTHER
LanZhou University
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
The First Municipal hospital of Ningbo
UNKNOWN
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Tianjin Medical University General Hospital
OTHER
ShenZhen KYD Biomedical Technology Co., Ltd.
INDUSTRY
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Jian'an Wang,MD,PhD
President of the Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
Principal Investigators
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Jian-an Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Dongxing Ma, MD
Role: PRINCIPAL_INVESTIGATOR
The Third Medical Center, Chinese People's Liberation Army General Hospital
Locations
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The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Ganzhou Municipal Hospital
Ganzhou, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The First Municipal hospital of Ningbo
Ningbo, Zhejiang, China
The Third Medical Center, Chinese People's Liberation Army General Hospital
Beijing, , China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, , China
General Hospital of Tianjin Medical University
Tianjin, , China
Countries
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References
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Fan Y, Ma D, Wang C, Luo J, Ling Z, Li S, Peng X, Zhang Z, Chu H, Wang J; investigators in the present study. A Membrane Modification Technique for Left Atrial Appendage Occlusion: A Multicenter Randomized Controlled Trial. JACC Asia. 2025 Mar;5(3 Pt 1):374-387. doi: 10.1016/j.jacasi.2024.12.008. Epub 2025 Feb 18.
Other Identifiers
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SAHZJU CT019
Identifier Type: -
Identifier Source: org_study_id
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