Physician Information

WHAT TREATMENT OF CRYPTOGENIC STROKE WILL REDUCE THE LIKELIHOOD OF A RECURRENT STROKE?
Evidence to date indicates there may be a connection between Patent Foramen Ovale (PFO) and cryptogenic stroke. 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 standard of care medical management in preventing recurrent cryptogenic strokes.

TRIAL DESIGN
Prospective multi-center randomized clinical trial to evaluate safety and efficacy.

RANDOMIZATION ARMS
Closure of the PFO with the AMPLATZER® PFO Occluder or treatment with the current medical standard of care.

PATIENT POPULATION:
Patients 18-60 years of age with a Cryptogenic stroke and PFO. Patients need to be enrolled within 270 days of their stroke.

BASELINE TESTING
Medical history; neurology evaluation; electrocardiogram (ECG) or Holter study; transesophageal echocardiography (TEE) with bubble study; magnetic resonance imaging (MRI) or cat scan (CT); magnetic resonance angiography (MRA), duplex sonography, CT angiography or contrast angiography; pregnancy test (pre-menopausal women and women of child bearing potential); and blood tests.

FOLLOW-UP
Patients will be evaluated pre-discharge (device only), at 1 month, 6 months, 12 months, 18 months, 24 months and annually through the post-market approval period.

END POINTS
Recurrence of nonfatal stroke, post-randomization death and fatal ischemic stroke.

CONTACT US
Thank you in advance for your assistance. Please call the trial coordinator for more information at 1-800-899-3925.

Notice of Availability for a Clinical Trial
Caution: Investigational device. Limited by Federal (U.S.) law to investigational use.