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

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

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.

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