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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
236
Interventional device, LAMax left atrial appendage closure system
Interventional device, Watchman® LAA Closure Device
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Ganzhou Municipal Hospital
Ganzhou, Jiangxi, China
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).
Time frame: 12 months post-implantation
Ischemic stroke, TIA, or Systemic embolism
A composite rate of ischemic stroke, TIA or systemic embolism.
Time frame: 12 months post-implantation
All stroke, systemic embolism, or cardiovascular/unexplained death
A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death.
Time frame: 12 months post-implantation
Incidence of MACCE events
A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, 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 Municipal hospital of Ningbo
Ningbo, Zhejiang, China
The Third Medical Center, Chinese People's Liberation Army General Hospital
Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
...and 2 more locations
Time frame: 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.
Time frame: 0 day
Success rate of withdrawing a delivery system after LAAC
It is one of the measures to describe the performance of delivery system.
Time frame: 0 day
Device performance post-implantation
A composite rate of device migration, embolization, regurgitation, perivalvular leak post-implantation.
Time frame: 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.
Time frame: 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.
Time frame: 7 days post-implantation