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

Non-valvular Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429646
• Other study ID #: SAHZJU CT019
• Status: Completed
• Phase: N/A
• Start date: April 20, 2019
• Est. completion date: June 10, 2021

Study information

• Verified date: May 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 10, 2021
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Intervention

Device:
• 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

Locations

Country	Name	City	State
China	The Third Medical Center, Chinese People's Liberation Army General Hospital	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing
China	Ganzhou Municipal Hospital	Ganzhou	Jiangxi
China	The Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The First Municipal hospital of Ningbo	Ningbo	Zhejiang
China	Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine	Shanghai
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	General Hospital of Tianjin Medical University	Tianjin

Sponsors (14)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

First Affiliated Hospital of Guangxi Medical University, Ganzhou Municipal Hospital, General Hospital of Tianjin Medical University, LanZhou University, Second Affiliated Hospital of Nanchang University, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, ShenZhen KYD Biomedical Technology Co., Ltd., The First Affiliated Hospital of Nanchang University, The First Hospital of Jilin University, The First Municipal hospital of Ningbo, The Second Affiliated Hospital of Chongqing Medical University, The Second Hospital of Hebei Medical University, The Third Medical Center, Chinese People's Liberation Army General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ischemic stroke, TIA, or Systemic embolism	A composite rate of ischemic stroke, TIA or systemic embolism.	12 months post-implantation
Secondary	All stroke, systemic embolism, or cardiovascular/unexplained death	A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death.	12 months post-implantation
Secondary	Incidence of MACCE events	A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.	12 months post-implantation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Success rate of withdrawing a delivery system after LAAC	It is one of the measures to describe the performance of delivery system.	0 day
Secondary	Device performance post-implantation	A composite rate of device migration, embolization, regurgitation, perivalvular leak post-implantation.	12 months post-implantation
Secondary	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
Secondary	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