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

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.

Study Overview

• Status: Completed
• Conditions: Non-valvular Atrial Fibrillation
• Intervention / Treatment: Device: Percutaneous left atrial appendage closure-LAMax; Device: Percutaneous left atrial appendage closure-Watchman

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 Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100039
    • The Third Medical Center, Chinese People's Liberation Army General Hospital
  • Chongqing, China, 400010
    • The Second Affiliated Hospital of Chongqing Medical University
  • Shanghai, China, 200011
    • Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine
  • Tianjin, China, 300020
    • General Hospital of Tianjin Medical University
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
  • Hebei
    • Shijiazhuang, Hebei, China, 050003
      • The Second Hospital of Hebei Medical University
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341001
      • Ganzhou Municipal Hospital
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330000
      • The Second Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital, School of Medicine, Zhejiang University
    • Ningbo, Zhejiang, China, 315010
      • The First Municipal hospital of Ningbo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAMax left atrial appendage occluder; Intervention device, LAMax left atrial appendage closure system	Device: Percutaneous left atrial appendage closure-LAMax; Interventional device, LAMax left atrial appendage closure system
Active Comparator: Watchman (control); Intervention device, Watchman® LAA Closure Device	Device: Percutaneous left atrial appendage closure-Watchman; Interventional device, Watchman® LAA Closure Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful sealing of the LAA	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).	12 months post-implantation
Ischemic stroke, TIA, or Systemic embolism	A composite rate of ischemic stroke, TIA or systemic embolism.	12 months post-implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All stroke, systemic embolism, or cardiovascular/unexplained death	A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death.	12 months post-implantation
Incidence of MACCE events	A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.	12 months post-implantation
Major Bleeding post-device implant	Major bleeding rate at 12 months post-implant: defined as Type 3a or greater based on the Bleeding Academic Research Consortium (BARC) definition.	12 months post-implantation
Success rate of device collapse and reposition during implantation procedure	It is one of the measures to describe device performance during implantation procedure.	0 day
Rate of cardiac temponade during implantation procedure	It is one of the measures to describe the performance of device and delivery system during implantation procedure.	0 day
Success rate of delivering an occlusion device to the LAA by the delivery system	It is one of the measures to describe the performance of delivery system during implantation procedure.	0 day
Success rate of withdrawing a delivery system after LAAC	It is one of the measures to describe the performance of delivery system.	0 day
Device performance post-implantation	A composite rate of device migration, embolization, regurgitation, perivalvular leak post-implantation.	12 months post-implantation
Device success rate	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.	0 day
Perioperative clinical success rate	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.	7 days post-implantation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: The First Affiliated Hospital of Nanchang University; LanZhou University; The Second Hospital of Hebei Medical University; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; The First Hospital of Jilin University; The Second Affiliated Hospital of Chongqing Medical University; Second Affiliated Hospital of Nanchang University; First Affiliated Hospital of Guangxi Medical University; The Third Medical Center, Chinese People's Liberation Army General Hospital; Ganzhou Municipal Hospital; The First Municipal hospital of Ningbo; General Hospital of Tianjin Medical University; ShenZhen KYD Biomedical Technology Co., Ltd.
• Investigators: Principal Investigator: Dongxing Ma, MD, The Third Medical Center, Chinese People's Liberation Army General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2019
• Primary Completion (Actual): November 11, 2020
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Ischemic Stroke; Left Atrial Appendage Closure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SAHZJU CT019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No