A number of doctors believe that a common heart condition called a patent foramen ovale (PFO) may be one cause of stroke and TIA since, under certain conditions; it will allow blood not yet filtered by the lungs to enter the arteries feeding the brain. If this blood contains debris or a clot, these can either block or cause narrowing in the artery, stopping or reducing the blood supply.

CLOSURE I is a randomized clinical trial comparing medical therapy to device closure in PFO-Stroke/TIA patients. It is the first and largest clinical trial of therapy an in these patients. CLOSURE I has been approved by the U.S. Food and Drug Administration (FDA) and the Canadian Therapeutic Product Directorate (TPD). There is a non-surgical method to close a PFO using a permanent implant device; however no device has been approved by the FDA for the use in patients.

The goal of CLOSURE I is to gather data comparing device closure to medical therapy, and determine if the device is both safe and more effective, than medical therapy. If the study is positive for the device the data will be submitted to the FDA for consideration for approval. If you or someone you know has recently had a stroke and are interested in finding out more about CLOSURE I, please click here for more trial information.