OPTION Clinical Trial Guidelines

Thank you for your interest in the OPTION Trial.  This trial is active and has reached full enrollment.


 

OPTION - What is the OPTION Clinical Trial - Boston Scientific

The purpose of the OPTION trial is to determine if left atrial appendage closure with the WATCHMAN FLXTM Implant is a reasonable alternative to blood thinners for stroke protection following AFib ablation.​​

By joining this study, you may have the opportunity to receive the WATCHMAN FLX Implant.* If you agree to be in this study, you will be expected to visit your study doctor for required screenings. You also may be required to attend follow-up visits about once a year for three years.​

See the Implant Procedure

NOTE: The OPTION Trial uses the WATCHMAN FLXTM Left Atrial Appendage Closure Device, which is an investigational device and not available for sale in the U.S. WATCHMAN FLXTM  is CE Marked.
  

Is OPTION Right For Me?

You may be a candidate for the OPTION clinical trial if you can answer yes to the following questions:

  I have been diagnosed with AFib not caused by a heart valve problem.​
✓   I have had or have been recommended for an AFib ablation.​
   I am interested in an alternative to the long-term use of blood thinners for stroke risk

  

Learn More About OPTION

If you answered yes to all of the above, consider talking to your heart doctor or locating your nearest OPTION implanting center.

  

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.

 

Top