Thank you for your interest in the OPTION Trial. This trial is active and has reached full enrollment.
OPTION - Find a Trial Site - Boston Scientific
Boston Scientific has selected sites to be OPTION investigational centers. If you think you may be an OPTION candidate, talk to your heart doctor or reach out to an OPTION center near you to discuss next steps.
If you're interested in understanding where the trial centers are in your area, visit clinicaltrials.gov.
WATCHMAN FLX is an FDA approved device being studied for an expanded indication as a first line therapy vs OAC for post-ablation NVAF patients. The use of WATCHMAN or WATCHMAN FLX as a first-line therapy for stroke risk reduction in post-ablation NVAF patients is considered investigational.
Important Safety Information
The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke.
With all medical procedures there are risks associated with the implant procedure and the use of the device. The risks include but are not limited to accidental heart puncture, air embolism, allergic reaction, anemia, anesthesia risks, arrhythmias, AV (Arteriovenous) fistula, bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, blood clot or air bubbles in the lungs or other organs, bruising at the catheter insertion site, clot formation on the device, cranial bleed, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, hypotension, infection/pneumonia, pneumothorax, pulmonary edema, pulmonary vein obstruction, renal failure, stroke, thrombosis and transient ischemic attack. In rare cases death can occur.
Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the device.