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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Trial Summary
Trial Overview
Inclusion Criteria

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
62
sites
University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Tufts Medical Center
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Moses H Cone Memorial Hosp
1200 North Elm Street
Greensboro, North Carolina 27401
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Greensboro, NC
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St. Vincent's Medical Center
1 Shircliff Way
Jacksonville, Florida 32204
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Jacksonville, FL
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Univ of Minnesota
Minneapolis, Minnesota 55455
(612) 625-5000
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University of Rochester
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Neurology and Neuroscience Associates
Akron, Ohio 44320
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Akron, OH
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Albany Medical Center
Albany, New York 12208
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Lehigh Valley Hospital
1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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DENT Neurologic Institute
Amherst, New York 14226
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University of Alabama
Birmingham, Alabama 35294
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University of Calgary
Calgary, Alberta
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charleston Area Medical Center
Charleston, West Virginia 25304
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Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey 08034
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Northwestern University
303 East Superior Street
Chicago, Illinois 60611
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University Hospitals of Cleveland
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
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Ohio State University
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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UT Southwestern Medical School
Dallas, Texas 75390
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University of Colorado
Denver, Colorado 80210
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Ruan Neurology
Des Moines, Iowa 50314
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St. Mary's Duluth Clinic
Duluth, Minnesota 55805
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Penn State Milton South Hershey Medical Center
Hershey, Pennsylvania 17033
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University of Texas Houston Health Science Center
Houston, Texas 77030
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Indiana Heart Physicians
Indianapolis, Indiana 46237
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University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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Kansas University Medical Center
Kansas City, Kansas
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Lancaster General Hospital
555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
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St. Mary's Medical Center
Langhorne, Pennsylvania 19067
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University of Kentucky
Lexington, Kentucky
859) 257-9000
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South Denver Cardiology Associates
Littleton, Colorado 80120
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Littleton, CO
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Lac & Usc Medical Center
Los Angeles, California 90033
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Los Angeles, CA
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UCLA
Los Angeles, California 90095
(310) 825-4321
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Medical Center of the Rockies
Loveland, Colorado 80538
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University of Wisconsin Hospital
Madison, Wisconsin 53792
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Marshfield Clinic
Marshfield, Wisconsin 54449
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Medical College of Wisconsin
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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Abbott Northwestern Hospital
800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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St. Thomas Neurology
Nashville, Tennessee 37205
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Vanderbilt University
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
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Ochsner Clinic Foundation
New Orleans, Louisiana 70121
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University of Medicine and Dentistry of New Jersy
Newark, New Jersey 07103
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Summit Medical Center
Oakland, California 94609
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Univ of Nebraska Med Ctr
Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Neurologic Associates Inc
Palos Heights, Illinois 60463
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OSF St. Francis Medical Center
530 NE Glen Oak Ave
Peoria, Illinois 61637
(309) 655-2000
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Providence St. Vincents Medical Center
Portland, Oregon 97225
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Portland, OR
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Oregon Stroke Center, OHSU
Portland, Oregon 97329
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Washington University
Saint Louis, Missouri 63110
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Methodist Hospital/Park Nicollet Medical Center
Saint Louis Park, Minnesota 55426
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Sharp Memorial Hospital
7901 Frost Street
San Diego, California 92123
858-939-3400
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Kaiser Permanente
San Francisco, California 94115
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Mayo Clinic
Scottsdale, Arizona 85259
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UW Medicine Stroke Center
Seattle, Washington 98104
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North Central Heart Institute
Sioux Falls, South Dakota 57108
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Southern Illinois University Neurology
Springfield, Illinois 62702
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Midatlantic Cardiovascular Associates
Towson, Maryland 21014
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Sentara Virginia Beach General Hospital
Virginia Beach, Virginia 23454
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George Washington University Hospital
Washington, District of Columbia 20037
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MedStar Washington Hospital Center
110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
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