Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
NCT ID: NCT00465270
Last Updated: 2019-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
980 participants
INTERVENTIONAL
2003-08-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Device
AMPLATZER PFO Occluder
AMPLATZER PFO Occluder
patent foramen ovale closure device
Standard or Care - Medical Management
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
Interventions
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AMPLATZER PFO Occluder
patent foramen ovale closure device
Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
Eligibility Criteria
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Inclusion Criteria
* Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
* Subjects willing to participate in follow-up visits
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Saver, MD
Role: PRINCIPAL_INVESTIGATOR
UCLA Stroke Center
John D Carroll, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Richard Smalling, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Houston Health Science Center
David Thaler, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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University of Alabama
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
LAC + USC Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Summit Medical Center
Oakland, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Neurologic Associates Inc
Palos Heights, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Southern Illinois University Neurology
Springfield, Illinois, United States
Indiana Heart Physicians
Indianapolis, Indiana, United States
Ruan Neurology
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Kansas University Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Midatlantic Cardiovascular Associates
Towson, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
St. Mary's Duluth Clinic
Duluth, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Methodist Hospital/Park Nicollet Medical Center
Saint Louis Park, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey, United States
University of Medicine and Dentistry of New Jersy
Newark, New Jersey, United States
Albany Medical Center
Albany, New York, United States
DENT Neurologic Institute
Amherst, New York, United States
University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Neurology and Neuroscience Associates
Akron, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Providence St. Vincent's Medical Center
Portland, Oregon, United States
Oregon Stroke Center, OHSU
Portland, Oregon, United States
LeHigh Valley Hospital
Allentown, Pennsylvania, United States
Penn State Milton South Hershey Medical Center
Hershey, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
St. Mary's Medical Center
Langhorne, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
North Central Heart Institute
Sioux Falls, South Dakota, United States
St. Thomas Neurology
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
UT Southwestern Medical School
Dallas, Texas, United States
University of Texas Houston Health Science Center
Houston, Texas, United States
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States
UW Medicine Stroke Center
Seattle, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Countries
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References
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Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.
Carroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013 Mar 21;368(12):1092-100. doi: 10.1056/NEJMoa1301440.
Related Links
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Related Info
Other Identifiers
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G990318
Identifier Type: -
Identifier Source: secondary_id
AGA-006
Identifier Type: -
Identifier Source: org_study_id
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