Adults with Cognitive Heart Disease (ACHD) now outnumber children with CHD. ACHD patients can demonstrate some neurocognitive deficits which may reduce their quality of life. The goal of this research is to determine if the mind's ability to resist damage of the brain can impact the development and neurocognitive outcomes in ACHD patients.

The GORE RELIEF Clinical study is evaluating if anti-clotting medications and/ or closure of Patent foramen ovale (PFO) using the GORE® CARDIOFORM Septal Occluder device in the heart will reduce migraine headaches in adults. The purpose of the study is to investigate whether patients who take a certain type of medication and have a decrease in migraine headaches will also have a decrease in migraine headaches after closure of the PFO, without having to take the medication long-term. It will also look at how safe the study device is (safety) in closing the PFO. The study is randomized and blinded; subjects will have an equal chance of being assigned study medication or placebo pills.

Subjects entering this long-term safety extension (LTSE) study must have successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit and are eligible for continuation of treatment beyond Month 12, if applicable. Subjects may be enrolled into the LUM-201-02 study, having met all enrollment criteria, following successful completion of 12, 18, or 24 months of treatment in a pediatric LUM-201 GHD study.
Subjects who have met the AHV ≥ 6.7 growth criterion and have continued on treatment beyond the Month 12 visit in the LUM-201-01 trial may transition into the LUM-201-02 trial at Month 18 visit. For these subjects, AHV at Month 24 will be compared to AHV at Month 12, and if it is confirmed to be ≥ 80% of the Month 12 AHV, continued treatment with LUM-201 will be offered.