This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Nanfang Hospital
Guangzhou, Guangdong, China
The first Affiliated Hospital of Guangzhou medical University
Guangzhou, Guangdong, China
Combined endpoint
All Stroke or Systemic embolism or Cardiovascular death
Time frame: 2 year
All bleeding event
Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment.
Time frame: 2 year
Major bleeding event
An overt bleeding accompanied by one or more of the following: a decrease in hemoglobin level of 20 g/l or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding
Time frame: 2 year
Technical and procedure related event
A pericardial effusion with a need for drainage, surgical or pericardiocentesis, or cardioembolic event during the procedure, or significant periprocedural bleeding (i.e. major vascular bleeding with a need for surgical revision, or blood concentrate transfusion), or device embolization, or thrombus of the device with a consequent cardioembolic event.
Time frame: 45 days
Cognitive function change
Montreal Cognitive Assessment(MoCA) will be performed to detect cognitive function change.The differences between the MoCA test score in WATCHMAN group and in a control group of Rivaroxaban
Time frame: 2 year
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The first affiliated hospital of Jinan university
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The second Affiliated Hospital of Guangzhou medical University
Guangzhou, Guangdong, China
Guangdong Cardiovascular Institute, Guangdong General Hospital
Guangzhou, Guangdong, China
The Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China