Ablations & Randomization Timing
- Patients must be randomized between 90 and 180 days following their ablation
- Informed consent occurs after the ablation
- Ablation and potential WATCHMAN FLXTM implant must occur within 10 days of randomization
- Informed consent occurs prior to the ablation
Why The OPTION Trial?
- Post-ablation patients are looking for alternatives to OAC to manage their stroke risk
- Based on the patient stroke risk profile (CHA2DS2-VASc => 2), current guidelines recommend the continuation of OAC post ablation
- Over 70% of ablation patients are expected to be on an OAC indefinitely per guidelines1
- There are no large randomized trials to assess the safety of discontinuing OAC in this post-ablation patient population
- The OPTION Clinical Trial is the largest global, prospective, randomized clinical trial to date in the LAAC space comparing WM vs. NOAC in the control arm.
* Caution: The WATCHMAN FLX™ Left Atrial Appendage Closure Device is an investigational device and is not available for sale in the U.S. ©2019 Boston Scientific Corporation or its affiliates. All rights reserved.
1. January, CT. et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation. JACC. 2014; doi: 10.1016/j.jacc.2014.03.022