Clinical trial NCT04429646: LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke
Official title: A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the LAMax LAA Closure System Compared to the Watchman® LAAC Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-valvular Atrial Fibrillation
Keywords: Atrial Fibrillation
Left Atrial Appendage Closure
Ischemic Stroke
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Third Medical Center, Chinese People's Liberation Army General Hospital
name: The Second Affiliated Hospital of Chongqing Medical University
name: Ganzhou Municipal Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: The Second Hospital of Hebei Medical University
name: The First Hospital of Jilin University
name: LanZhou University
name: Second Affiliated Hospital of Nanchang University
name: The First Affiliated Hospital of Nanchang University
name: The First Municipal hospital of Ningbo
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Tianjin Medical University General Hospital
name: ShenZhen KYD Biomedical Technology Co., Ltd.
First posted: 2020-06-12
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Endpoint Classification: Safety/Efficacy Study Masking: Open Label
Primary purpose: PREVENTION

Brief summary: This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage (LAA) Closure System.

Detailed description: This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage Closure (LAAC) System. Subjects with non-valvular Atrial Fibrillation will be randomized in a 1:1 ratio to the Experimental Treatment Arm (LAMax LAAC system) or the Control Arm (Watchman LAAC system, Boston Scientific Inc., USA). The trial is designed to demonstrate that safety and effectiveness of the LAMax device are non-inferior to the Watchman device.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old with non-valvular atrial fibrillation (AF) and CHA2DS2-VASc ≥2
* 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:

1. . Patients with other diseases other than AF who need long-term warfarin anticoagulation therapy;
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.

Primary outcomes:
measure: Successful sealing of the LAA
timeFrame: 12 months post-implantation
measure: Ischemic stroke, TIA, or Systemic embolism
timeFrame: 12 months post-implantation
Secondary outcomes:
measure: All stroke, systemic embolism, or cardiovascular/unexplained death
timeFrame: 12 months post-implantation
measure: Incidence of MACCE events
timeFrame: 12 months post-implantation
measure: Major Bleeding post-device implant
timeFrame: 12 months post-implantation
measure: Success rate of device collapse and reposition during implantation procedure
timeFrame: 0 day
measure: Rate of cardiac temponade during implantation procedure
timeFrame: 0 day
measure: Success rate of delivering an occlusion device to the LAA by the delivery system
timeFrame: 0 day
measure: Success rate of withdrawing a delivery system after LAAC
timeFrame: 0 day
measure: Device performance post-implantation
timeFrame: 12 months post-implantation
measure: Device success rate
timeFrame: 0 day
measure: Perioperative clinical success rate
timeFrame: 7 days post-implantation
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Ganzhou
country: China
facility: Ganzhou Municipal Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Ningbo
country: China
facility: The First Municipal hospital of Ningbo
state: Zhejiang
city: Beijing
country: China
facility: The Third Medical Center, Chinese People's Liberation Army General Hospital
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jian-an Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Medical Center, Chinese People's Liberation Army General Hospital
name: Dongxing Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: