OPTION

Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation (OPTION)

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Objective

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high-risk patients with non-valvular atrial fibrillation.

Eligibility

  • The subject is of legal age to participate in the study per the laws of their respective geography.
  • Underwent a prior catheter ablation procedure for non-valvular AF between 90 and 180 days prior to randomization (sequential) or is planning to have clinically indicated catheter ablation within 10 days of randomization (concomitant).
  • The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
  • The subject is deemed to be suitable for the defined protocol pharmacologic regimen.
  • The subject is able to undergo TEE examinations.
  • The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial.
  • The subject is able and willing to return for required follow-up visits and examinations.

NCT ID

NCT03795298