Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-Center, Pilot Study to Compare the Safety and Effectiveness of WATCHMAN Left Atrial Appendage Occlusion Device With Rivaroxaban for Stroke Prevention in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation, Stroke

Intervention / Treatment
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* Device: WATCHMAN Left Atrial Appendage Occlusion Device
* Drug: Rivaroxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paroxysmal, persistent or permanent non-valvular atrial fibrillation Eligible for LAAO and long-term rivaroxaban therapy Calculated CHA2DS2-VASc score of 2 or greater. Exclusion Criteria: Contraindicated/allergic to aspirin, clopidogrel and novel oral anticoagulants. Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment. History of atrial septal repair or has an atrial septal defect/patent foramen ovale device. History of valvular heart disease. Implanted mechanical valve prosthesis. New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction less than 30%. Patient has left atrial/left atrial appendage thrombus screened by echocardiography Platelet<100*109/L or hemoglobin<100g/L Expected lifespan less than 1 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WATCHMAN LAA Occlusion Device<br>Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device. | Device: WATCHMAN Left Atrial Appendage Occlusion Device<br> <br> * Other names: WATCHMAN Left Atrial Appendage Closure;|
| Active Comparator: Rivaroxaban<br>Subjects assigned to receive the Rivaroxaban therapy. | Drug: Rivaroxaban<br> <br> * Other names: Novel Oral Anticoagulant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint | All Stroke or Systemic embolism or Cardiovascular death | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All bleeding event | Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment. | 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 | 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. | 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 | 2 year |