Is there a link between PFO and Stroke?
The purpose of the Gore REDUCE Clinical Study is to determine whether closing a patient’s PFO with the GORE® Septal Occluder plus taking some medication or taking medications alone without closing the PFO, is better at reducing the risk of having another stroke.
A patent foramen ovale is a common opening in the wall (septum) between the two upper chambers (the right and left atria) of the heart. In most cases, this opening closes around the time of birth. If the opening remains after birth, it can allow the blood to mix in the two upper chambers of the heart.
If the opening is left untreated, it may increase the risk for stroke by allowing clots to cross from the right side of the heart to the left. It is not known for sure if closing the PFO reduces the risk for another stroke.
About the Device in the Clinical Study
The GORE® Septal Occluder is made up of an implantable portion and a catheter delivery system. The implantable part is shaped into a double disc which closes around both sides of the PFO, sealing off the hole.
At the current time, the GORE® Septal Occluder does not have US FDA approval for the specific PFO closure indication, although it is approved for this use in several other countries.
The maker of the GORE® Septal Occluder hopes to gain approval for the PFO indication in the US after this Research Study is completed.
The Gore REDUCE Clinical Study is recruiting about 700 patients from approximately 80 different hospitals in the US and Europe. To find out if you may qualify to be part of the study click on “Am I Candidate.”