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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shulin Wu
• Collaborators: Beijing Anzhen Hospital; First Affiliated Hospital of Jinan University; First Affiliated Hospital, Sun Yat-Sen University; Guangdong Medical College; Nanfang Hospital of Southern Medical University; Second Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Guangzhou Medical University; Wuhan Asia Heart Hospital
• Treatments: Anticoagulants; Rivaroxaban

Criteria

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