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THE RESPECT® PFO CLINICAL TRIAL
It is not yet known what the best treatment is to reduce the risk of a recurrent stroke, but evidence suggests that there may be a connection between Patent Foramen Ovale (PFO) and cryptogenic stroke, or a stroke where the origin is unknown. AGA Medical Corporation is conducting a randomized Clinical Trial called RESPECT to investigate whether percutaneous PFO Closure with the AMPLATZER PFO Occluder Device is superior to current standard of care treatment in the prevention of recurrent embolic, cryptogenic stroke.

WE NEED YOUR HELP
AGA Medical is seeking persons between the ages of 18 and 60 who have suffered a cryptogenic stroke in the last 270 days and who have a documented PFO with no other major health conditions. With your help, we can answer the question. Click on the Physician Locator to find a RESPECT Physician nearest you.

DEFINITION OF TERMS

AMPLATZER PFO Occluder Device - A self-expanding, double-disk wire mesh device, with a connecting waist, that is intended to close the opening, or PFO, between the upper chambers of the heart. The device is navigated, via a catheter, through large veins or arteries to the heart.

Catheter - A hollow tube that is used to navigate through veins or arteries, usually from the groin, to provide access to the heart without open-heart surgery.

Cryptogenic Stroke - A stroke from an unknown cause.

Embolic Stroke - A sudden obstruction of a blood vessel by debris.

Patent Foramen Ovale (PFO) - An opening between the upper chambers of the heart (atria) that normally closes after birth. This opening allows some blood to bypass the filtering system of the lungs. As a result, unfiltered, deoxygenated blood may be pumped throughout the body and brain.

Percutaneous - Through the skin and in this case, using a catheter.

Platelets - The part of blood that forms clots around injuries.

Randomized - A system by which the outcome of a decision will not be predictable before-hand. In the case of the RESPECT Trial, the treatment you receive is determined by chance.

Recurrent - Relapse, or to happen again.

Standard of care treatment - Medications that thin the blood by either making the platelets less "sticky" or by acting on other blood components that help with clotting to decrease their activity.

Stroke - A sudden loss of brain function caused by a blockage or rupture of a blood vessel to the brain, characterized by loss of muscular control, loss of sensation or consciousness, dizziness, slurred speech, or other symptoms that vary with the extent and severity of the damage to the brain. Also called cerebral accident or cerebrovascular accident.