Research Study for Patients with a Patent Foramen Ovale (PFO)

Study Summary

The University of Chicago and Dr. Neeraj Jolly are conducting a research study for subjects who have a patent foramen ovale (PFO) that should be closed, and have already had two strokes despite being on medication. A PFO is a hole or flap between the upper chambers of the heart. In this study, an experimental device will be used to close the PFO. This device is experimental because it has not been approved by the United States Food and Drug Administration (FDA). Once the PFO has been closed, you will be asked to come back for scheduled follow-up visits, and the results of the implant procedure and follow-up visits will be collected and reported.

The study device is a self-expandable, double disc device made from a wire mesh. The two discs are linked together by a short connecting waist. The discs and waist have fabric sewn into them. The fabric used in the device is the same as that used by surgeons to close other heart defects. The device will remain permanently in the heart.

Your study participation will last for one year. You will have a procedure to implant the device and will stay in the hospital for one or two nights. You will have a follow-up examination six months and one year after the device is implanted. These visits may include a physical exam, neurological exam, chest x-ray, EKG (measures electrical activity of the heart), and echocardiographic evaluation (ultrasound of the heart) to see if the PFO is closed.

Benefits

You may not benefit directly from this research if, for example, the experimental device does not work. You may benefit if the experimental device proves to be safer and/or more effective than any other treatment you might have received. The information learned about the experimental device and how it works may be helpful to patients with PFO in the future.

Participation Details

Initial selection criteria include:

• Must be age 18 or older
• Must have a PFO, have had 2 strokes and have failed standard drug treatment
• Must not be pregnant during the study
• Must meet study medical criteria as evaluated by Dr. Jolly

Study Director: Dr. Neeraj Jolly
Department: Cardiology

For more information contact:
Bridget Galetti, RN
bgaletti@medicine.bsd.uchicago.edu
(773) 702-0347

IRB: #16295A