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

Shulin Wu

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation; Stroke

Treatments: Device: WATCHMAN Left Atrial Appendage Occlusion Device; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT02549963

GDCI 201501

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

WATCHMAN LAA Occlusion Device

Experimental group

Description:

Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device.

Treatment:

Device: WATCHMAN Left Atrial Appendage Occlusion Device

Rivaroxaban

Active Comparator group

Description:

Subjects assigned to receive the Rivaroxaban therapy.

Treatment:

Drug: Rivaroxaban