Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 60
Updated:2/20/2019
Start Date:August 2003
End Date:May 2016

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Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)

The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO)
closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical
treatment in the prevention of recurrent embolic stroke.

The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the
non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke
due to presumed paradoxical embolism within the last 270 days.

Inclusion Criteria:

- Subjects who have had a cryptogenic stroke within the last 270 days

- Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)

- Subjects willing to participate in follow-up visits

Exclusion Criteria:

- Subjects with intracardiac thrombus or tumor

- Subjects who have an acute or recent (within 6 months) myocardial infarction or
unstable angina

- Subjects with left ventricular aneurysm or akinesis

- Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)

- Subjects with another source of right to left shunt identified at baseline, including
an atrial septal defect and/or fenestrated septum

- Subjects with contraindication to aspirin or Clopidogrel therapy

- Pregnant or desire to become pregnant within the next year
We found this trial at
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Sioux Falls, South Dakota 57108
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800 Washington St
Boston, Massachusetts 02111
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5801 South Ellis Avenue
Chicago, Illinois 60637
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1200 North Elm Street
Greensboro, North Carolina 27401
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1 Shircliff Way
Jacksonville, Florida 32204
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Minneapolis, Minnesota 55455
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60 Crittenden Blvd # 70
Rochester, New York 14642
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Albany, New York 12208
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
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Amherst, New York 14226
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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Birmingham, Alabama 35294
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Calgary, Alberta
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171 Ashley Avenue
Charleston, South Carolina 29425
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Charleston, West Virginia 25304
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Cherry Hill, New Jersey 08034
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303 East Superior Street
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11100 Euclid Ave
Cleveland, Ohio 44106
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281 W. Lane Ave
Columbus, Ohio 43210
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Indianapolis, Indiana 46237
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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Kansas City, Kansas
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555 N Duke St
Lancaster, Pennsylvania 17602
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Langhorne, Pennsylvania 19067
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Lexington, Kentucky
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Los Angeles, California 90095
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Madison, Wisconsin 53792
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Marshfield, Wisconsin 54449
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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800 E 28th St
Minneapolis, Minnesota 55407
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2201 West End Ave
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Emile St
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Palos Heights, Illinois 60463
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530 NE Glen Oak Ave
Peoria, Illinois 61637
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Saint Louis Park, Minnesota 55426
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7901 Frost Street
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Washington, District of Columbia 20037
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110 Irving St NW
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