Aurora St. Luke’s Medical Center in Milwaukee is the first site in Wisconsin to join a clinical trial investigating if a device implanted into the heart can reduce migraine headaches in certain patients.
The study, known as RELIEF, is designed to evaluate the use of the GORE® CARDIOFORM Septal Occluder for migraine headache relief in eligible patients with a hole in their heart called a patent foramen ovale (PFO).
Before birth, the PFO connects the top two chambers of a fetus’s heart to allow oxygen-rich blood to flow directly from the mother to the fetus, bypassing the fetus’s lungs, which do not yet work. Normally, the PFO closes after birth. But for one out of every four people, the PFO remains open, which may allow blood to flow directly from the right side of the heart to the left.
“Many people with a PFO suffer from migraines,” said interventional cardiologist Tanvir Bajwa, MD, Advocate Aurora Research Institute’s site principal investigator for the study. “It is possible that the direct flow of blood from the right atrium to the left atrium could carry certain substances or particles, which the lungs would normally filter out, that could cause these migraines.”
The GORE® CARDIOFORM Septal Occluder is designed for permanent placement into the heart to effectively close a PFO. A team of cardiologists insert the device via a small tube called a catheter through a small incision, usually located in the right groin area. The doctors then carefully thread the catheter, guided by imaging technology, through the body’s chain of blood vessels until it reaches the placement point in the heart, at which point the device is released and expanded to full size, and the catheter is removed.
The GORE® CARDIOFORM Septal Occluder was previously approved by the U.S. Food and Drug Administration (FDA) for the closure of a PFO in order to prevent recurrent strokes in certain patients. Dr. Bajwa led a clinical trial at Aurora St. Luke’s that contributed to the device’s FDA approval for its stroke indication.
The RELIEF study will evaluate the same device and implantation procedure but for the treatment of migraine headaches. Because the device has not been approved for this use, it is considered investigational within the context of this study.
“Researchers have long observed the unanticipated reduction of migraine headaches following PFO closure of certain patients,” said Amit Acharya, PhD, chief research officer and system vice president for Advocate Aurora Health and the Research Institute. “The result, however, may be incidental. To date, no clinical trial has definitively proved the connection between PFO and migraine headaches.”
Investigators aim to enroll 150 participants with PFO and a history of migraines into the RELIEF study, which consists of two phases. In the first phase, participants will be randomly assigned to take either a medication or a placebo. Participants for whom the medication improves migraine symptoms will be eligible for the study’s second phase. In the second phase, participants will be randomly assigned to receive either the study device implantation procedure or a sham procedure.
The study, “GORE® CARDIOFORM Septal Occluder Migraine Clinical Study (RELIEF),” is sponsored by W. L. Gore & Associates, the device manufacturer.
To learn more about Advocate Aurora’s research, visit aurora.org/research.