Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

Are you eligible to participate in this study?

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

  • Conditions:
    Atrial Fibrillation
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who underwent a prior catheter ablation procedure for non-valvular AF between 90 and 180 days prior to randomization (sequential) or are planning to have clinically indicated catheter ablation within 10 days of randomization (concomitant).
    2. Subjects with a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
    3. Subjects deemed by the treating physician to be suitable for the protocol defined pharmacologic regimen
    4. Subjects able to undergo TEE examinations.
    5. Subjects able to understand and are willing to provide written informed consent to participate in the trial.
    6. Subjects who are 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 currently enrolled in another investigational study
    2. Subjects who require long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction
    3. Subject are deemed by the treating physician to be unsuitable for chronic anticoagulation and/or aspirin therapy due to bleeding risk, allergy, or other reasons.
    4. Subjects who had or are planning to have any cardiac or major non- cardiac interventional or surgical procedure
    5. Subjects who had a stroke or transient ischemic attack (TIA) within the 60 days prior to randomization.
    6. Subjects who had a prior major bleeding event per ISTH definition within the 14 days prior to randomization.
    7. Subjects who had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to randomization.
    8. Subjects with a history of atrial septal repair or has an ASD/PFO device.
    9. Subjects who had an implanted mechanical valve prosthesis in any position.
    10. Subjects who are of childbearing potential and are planning, or have plans to become pregnant during the time of the study
    11. Subjects who have a documented life expectancy of less than two years.
    12. Subjects who have a cardiac tumor
    13. Subjects with signs/symptoms of acute or chronic pericarditis.
    14. Subjects with contraindications (anatomical or medical) to percutaneous catheterization procedures.
    15. Subjects with documented NYHA Class IV heart failure or documented surgical closure of the left atrial appendage.
    16. Subjects who have an active infection



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