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.
Transcatheter closure of secundum ASD using a permanent implant is considered the standard of care for treatment of clinically significant ASD. Over the past twenty years, devices have evolved such that safety and effectiveness are equal or superior to surgical techniques while reducing the economic and psychological costs of care. Industry sources estimate that, globally, over half a million patients have received a septal occluder to treat atrial level shunts.
A key remaining drawback to all such devices is that they are permanent implants placed in a typically young population. Unlike surgical suture, which resorbs over time, all currently available septal occlusion implants are constructed with a metal framework that incorporates some amount of fabric-based material.
The reSept ASD Occluder is unique in that the framework of the implant is comprised of a bioresorbable material (PLGA) and is intended for use in patients with a clinically significant secundum ASD, who, in the judgment of their physician, require closure of the ASD and in whom a transcatheter approach is deemed appropriate.
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.