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