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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04429646

Enrollment

236

Registered

2020-06-12

Start date

2019-04-20

Completion date

2021-06-10

Last updated

2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-valvular Atrial Fibrillation

Keywords

Atrial Fibrillation, Left Atrial Appendage Closure, Ischemic Stroke

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.

Interventions

DEVICEPercutaneous left atrial appendage closure-LAMax

Interventional device, LAMax left atrial appendage closure system

DEVICEPercutaneous left atrial appendage closure-Watchman

Interventional device, Watchman® LAA Closure Device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Endpoint Classification: Safety/Efficacy Study Masking: Open Label

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).
Ischemic stroke, TIA, or Systemic embolism	12 months post-implantation	A composite rate of ischemic stroke, TIA or systemic embolism.

Secondary

Measure	Time frame	Description
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.
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.
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.
All stroke, systemic embolism, or cardiovascular/unexplained death	12 months post-implantation	A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death.
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.
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.
Success rate of withdrawing a delivery system after LAAC	0 day	It is one of the measures to describe the performance of delivery system.
Incidence of MACCE events	12 months post-implantation	A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026