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