REDUCE study is researching the safety and effectiveness of GORE® CARDIOFORM Septal Occluder (GSO ) device in closing the patent foramen ovale (PFO) in patients who have a PFO and had a stroke of unknown origin (cryptogenic stroke). This device has been approved by the United States Food and Drug Administration for this indication.
A PFO 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.
In most people, leaving the opening untreated has no negative consequences. However, in some patients who have had a stroke of unknown origin (cryptogenic stroke), the presence of a PFO may increase the risk of having another stroke if the opening is left untreated.
This is a multicenter cross-sectional pilot analysis of objective and subjective neurocognitive deficits (NCD) and genetics in the Adults with Congenital Heart Disease (ACHD) population ages 18-30 years with moderate and severe complexity of congenital heart disease (CHD).
The expectation is that studying NCD in ACHD will help to guide access to resources and appropriate medical care for these patients. This research should facilitate the use of targeted interventions in the ACHD population with NCD to enhance both long term quality of care and quality of life (QOL).