Trial | NCT02549963  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    rivaroxaban ...

  • Study Participants

    200
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 Started
Oct 31
2015
Primary Completion
Oct 31
2017
Anticipated
Last Update
Sep 24
2015
Estimate

Device WATCHMAN Left Atrial Appendage Occlusion Device

  • Other names: WATCHMAN Left Atrial Appendage Closure

Drug Rivaroxaban

  • Other names: Novel Oral Anticoagulant

WATCHMAN LAA Occlusion Device Experimental

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

Rivaroxaban Active Comparator

Subjects assigned to receive the Rivaroxaban therapy.

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
No Results Posted