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 had a stroke and have an opening in the heart called a Patent Foramen Ovale (PFO). Normally the PFO closes at or shortly after birth. In your case, the PFO has remained open and has allowed a blood clot to pass from the right side of your heart to the left side. Blood flowing from the left heart chamber can go to the brain, so a clot or piece of tissue crossing over through that opening could go to the brain and cause a stroke. This is thought to be the reason that you had a stroke.

The purpose of the research is to determine whether PFO closure with a PFO Occluder device is superior to current medical management in preventing recurrent strokes or transient ischemic attacks (TIAs). The PFO Occuder device in this study is experimental because it is not approved by US Food and Drug Administration (FDA)

Subjects are randomized (like flipping a coin) to one of two groups: device closure or medical management (taking blood thinning medicines to prevent clots).

Subjects who are randomized to the device group will have a procedure to implant the device and will stay in the hospital overnight. Subjects in both groups will be followed at one month, six months, 12 months, 18 months, 24 months and every year until the study closes. Your study participation may last for up to six years. Study visits will take place at the University of Chicago. These study visits may include a physical exam, neurological exam, stroke questionnaire, EKG or Holter monitoring, transesophageal echocardiography (TEE), and/or x-rays of the chest.

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 between the ages of 18 and 60 years
• Must have imaging evidence of a stroke or symptoms lasting more than 24 hours
• Must have a PFO
• 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: #11930B