LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke

Not Applicable

Completed

• Conditions: Non-valvular Atrial Fibrillation
• Interventions: Device: Percutaneous left atrial appendage closure-LAMax; Device: Percutaneous left atrial appendage closure-Watchman

• Registration Number: NCT04429646
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2019-04-20
• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-12
• Primary Completion: 2020-11-11
• Study Completion: 2021-06-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAMax left atrial appendage occluder	Percutaneous left atrial appendage closure-LAMax	Intervention device, LAMax left atrial appendage closure system
Watchman (control)	Percutaneous left atrial appendage closure-Watchman	Intervention device, Watchman® LAA Closure Device

Primary Outcome Measures

Name	Time	Method
Ischemic stroke, TIA, or Systemic embolism	12 months post-implantation	A composite rate of ischemic stroke, TIA or systemic embolism.
Successful sealing of the LAA	12 months post-implantation	A composite rate of successful sealing of the left atrial appendage (defined as residual flow ≤ 5 mm) at the 12-month visit documented by transesophageal echocardiogram (TEE).

Secondary Outcome Measures

Name	Time	Method
All stroke, systemic embolism, or cardiovascular/unexplained death	12 months post-implantation	A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death.
Success rate of device collapse and reposition during implantation procedure	0 day	It is one of the measures to describe device performance during implantation procedure.
Incidence of MACCE events	12 months post-implantation	A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.
Major Bleeding post-device implant	12 months post-implantation	Major bleeding rate at 12 months post-implant: defined as Type 3a or greater based on the Bleeding Academic Research Consortium (BARC) definition.
Device performance post-implantation	12 months post-implantation	A composite rate of device migration, embolization, regurgitation, perivalvular leak post-implantation.
Device success rate	0 day	A composite rate to describe that the device can be successfully delivered in place and successfully implanted, and angiography shows that the implanted device is in the right position, no residual flow or residual flow is less than 5 mm, and the delivery system can be successfully withdrawn.
Rate of cardiac temponade during implantation procedure	0 day	It is one of the measures to describe the performance of device and delivery system during implantation procedure.
Success rate of delivering an occlusion device to the LAA by the delivery system	0 day	It is one of the measures to describe the performance of delivery system during implantation procedure.
Success rate of withdrawing a delivery system after LAAC	0 day	It is one of the measures to describe the performance of delivery system.
Perioperative clinical success rate	7 days post-implantation	A composite rate to describe that the device's function is normal, including that it was successfully implanted, the residual flow was less than 5mm, the implanted device had no effect on mitral valve movement and pulmonary vein blood flow, and there was no major adverse event (MAE) at the time of discharge.

Trial Locations

Locations (12)

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

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The Third Medical Center, Chinese People's Liberation Army General Hospital; 🇨🇳 Beijing, China

The First Municipal hospital of Ningbo; 🇨🇳 Ningbo, Zhejiang, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Ganzhou Municipal Hospital; 🇨🇳 Ganzhou, 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 Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China