RESPECT Clinical Trial Overview

Stroke is the third leading cause of death among Americans¹, but nearly 40% of people who suffer a stroke have no known risk factors², such as high blood pressure and diabetes. The diagnosis for these patients is cryptogenic stroke, meaning stroke of an unknown origin or cause.

Medical researchers have suspected for some time that cryptogenic stroke could be linked to a common heart defect, patent foramen ovale (PFO). Studies have shown that nearly half of people who suffer a cryptogenic stroke also have a PFO, a small hole between the upper chambers of the heart.³

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The RESPECT Trial is a clinical study to determine if closing a PFO can reduce or eliminate the recurrence of cryptogenic stroke. AGA Medical LLC, is conducting the RESPECT Trial among cryptogenic stroke survivors who have PFOs.

The study will help establish the effectiveness of the company's AMPLATZER^® PFO Occluder, which will be implanted to close a PFO and be compared to standard of care medical management. The U.S. Food and Drug Administration considers the AMPLATZER PFO Occluder an experimental or investigational device.

Links:
Learn more about the RESPECT Trial
Learn more about stroke and PFO
Never Give Up: The Tedy Bruschi Story

¹ National Stroke Association
² Sacco, R. et al: Infarcts of Undetermined Cause: The NINCDS Stroke Data
   Bank. Annals of Neurology 25 (4), 1989
³ Lechat, P. et al: Prevalence of Patent Foramen Ovale in Subjects with Stroke.
   The New England Journal of Medicine (318), 1988