Study ID: OPTION
Comparison of anticoagulation with left atrial appendage closure after AF ablation
This trial is studying the FDA-approved WATCHMAN FLX™ implantable device to determine whether closing the left atrial appendage in patients who have undergone atrial fibrillation (AF) ablation is a reasonable alternative to oral anticoagulation. The study is comparing the device to oral anticoagulant treatments.
Eligible patients must have already undergone catheter ablation for non-valvular AF between 90 and 180 days prior to trial enrollment or are planning to undergo catheter ablation within 10 days of being randomized into this trial.
Participants are randomized into two study groups:
- Arm 1 receives the WATCHMAN FLX implant, including a modified post-implant drug regimen
- Arm 2 receives oral anticoagulants for the trial’s duration
This is a prospective, randomized, multicenter, global investigation 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.
The primary outcomes being measured are stroke, all-cause death, systemic embolism, and non-procedural bleeding within 36 months.
- Must have a CHA2DS2-VASc score of 2 or greater for males and 3 or greater for females
- Must be deemed suitable for the protocol’s drug regimen
- Must not require long-term anticoagulation therapy for reasons other than AF-related stroke-risk reduction
Other significant inclusion and exclusion criteria apply.
Clinical Research Nurse