Clinical Trial of the Week: Device trial to treat left atrial appendage closure in atrial fibrillation ablation patients

By Donna Loyle, communications manager, LIMR

 

The OPTION clinical trial is a randomized, multicenter study 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 (AF).

 

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

 

Inclusion criteria:

  • 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.

 

The primary outcomes being measured are stroke, all-cause death, systemic embolism, and non-procedural bleeding within 36 months.

 

The MLH principal investigator is Sheetal Chandhok, MD. The trial is approved for Bryn Mawr Hospital and Lankenau Medical Center. For more: https://www.mainlinehealth.org/research/clinical-trials/option

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