RESPECT: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment
Study of:
Patent Foramen Ovale (PFO) closure
A Patent Foramen Ovale (PFO) is a persistent, slit-like opening between the right and left atrial chambers of the heart. It usually closes shortly after birth, but in a small percentage of people this opening persists. The opening can lead to paradoxical emboli (blood clots) causing strokes, transient ischemic attacks (small strokes), or peripheral (lower extremity) embolic events. Closing these openings with a device like the Amplatzer PFO Occluder may prevent further neurological complications. The RESPECT Trial is a multi-centered randomized-control clinical trial to investigate whether percutaneous PFO closure is superior to current standard of care of medical treatment in the prevention of recurrent embolic stroke or transient attacks. A maximum of 500 patients will be enrolled at approximately 45 institutions. All patients must have suffered a cerebral infarction (stroke) within the last 90 days in order to participate in the trial. Patients will be randomized 1:1 to one of two treatment groups: (1) those who receive the Amplatzer PFO Occluder device and (2) those who receive current standard of care medical treatment. Patients will be followed for 2 years post randomization.
For more information about this study or the Interventional Cardiology Research program at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Carol Stone at 612-863-9124. |