Respect Trial - United States
AMPLATZER® PFO Occluder - Notice of Availability - Caution: Investigational device. Limited by Federal (U.S.) law to investigational use.
THE HEART AND STROKE CONNECTION
Evidence indicates there may be a connection between Patent Foramen Ovale (PFO) and cryptogenic stroke. Cryptogenic stroke is a stroke that occurs without the normal symptoms associated with stroke.
Patent Foramen Ovale is one potential suspected cause of cryptogenic stroke. The foramen ovale is a flap or tunnel shaped hole in the atrial septum during fetal development that allows blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. If this opening does not close shortly after birth, a Patent (or open) Foramen Ovale (PFO) results.
It is not known what the best treatment is to reduce the risk of a recurrent stroke. AGA Medical Corporation is conducting the RESPECT Clinical Trial to investigate whether closure of PFO is superior to medical management in preventing recurrent cryptogenic strokes.
Patients 18-60 years of age who have been diagnosed with one cryptogenic stroke and confirmation of a PFO may qualify for the RESPECT Trial. Trial design is a prospective multi-center randomized clinical trial to evaluate safety and efficacy. Closure of the PFO with the AMPLATZER® PFO Occluder, or treatment with the current medical standard of care are used to compare for efficacy and safety.
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