Randomization

OPTION Randomization Timing

Ablations & Randomization Timing

Sequential Arm:​

  • Patients must be randomized between 90 and 180 days following their ablation​
  • Informed consent occurs after the ablation​

Concomitant:​

  • Ablation and potential WATCHMAN FLXTM implant must occur within 10 days of randomization
  • Informed consent occurs prior to the ablation

Why The OPTION Trial?

  1. Post-ablation patients are looking for alternatives to OAC to manage their stroke risk

  2. ​Based on the patient stroke risk profile (CHA2DS2-VASc => 2), current guidelines recommend the continuation of OAC post ablation

  3. ​Over 70% of ablation patients are expected to be on an OAC indefinitely per guidelines1​

  4. There are no large randomized trials to assess the safety of discontinuing OAC in this post-ablation patient population​

  5. 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  

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