WUH: AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Randomized Controlled Trial

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Non-valvular Atrial Fibrillation
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects with documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation and has not been diagnosed with rheumatic mitral valvular heart disease
    2. Subjects who are at high risk of stroke or systemic embolism
    3. Subjects has an appropriate rationale to seek an alternative to warfarin or other anticoagulant medication
    4. Subjects deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term anticoagulation
    5. Subjects deemed suitable for LAA closure
    6. Subjects able to comply with the required medication regime post-device implant
    7. Subjects able to understand and is willing to provide written informed consent to participate in the trial
    8. Subjects able and willing to return for required follow-up visits and examinations

You may not be eligible for this study if the following are true:

    1. Subjects requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
    2. Subjects who are contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
    3. Subjects indicated for chronic P2Y12 platelet therapy inhibitor
    4. Subjects is considered at high risk for general anesthesia, in the opinion of the investigator, and/or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay
    5. Subjects has undergone atrial septal defect (ASD) repair or has an ASD closure device present
    6. Subjects has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
    7. . Subjects implanted with a mechanical valve prosthesis
    8. . Subjects has any of the customary contraindications for a percutaneous catheterization procedure
    9. Subjects has had a stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure
    10. Subjects who underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure
    11. Those who had myocardial infarction (MI) within 90 days prior to randomization
    12. New York Heart Association Class IV Congestive Heart Failure
    13. Subjects with symptomatic carotid disease
    14. History of idiopathic or recurrent venous thromboembolism
    15. Subjects who are pregnant or pregnancy is planned.
    16. Subjects with severe renal failure
    17. Subject has had a transient case of AF

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

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