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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00465270
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : September 4, 2018
Last Update Posted : February 18, 2019
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cryptogenic Stroke Device: AMPLATZER PFO Occluder Other: Standard of Care - Medical Management Not Applicable

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: AMPLATZER PFO Occluder
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
Actual Study Start Date : August 2003
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: Device
Device: AMPLATZER PFO Occluder
patent foramen ovale closure device

Active Comparator: Standard or Care - Medical Management
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Other: Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

Primary Outcome Measures :
  1. Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization [ Time Frame: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years. ]

    Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct.

    Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.

Secondary Outcome Measures :
  1. Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465270

Hide Hide 69 study locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
LAC + USC Medical Center
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
Summit Medical Center
Oakland, California, United States, 94609
Sharp Memorial Hospital
San Diego, California, United States, 92123
Kaiser Permanente
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
South Denver Cardiology Associates
Littleton, Colorado, United States, 80120
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
George Washington University Hospital
Washington, District of Columbia, United States, 20037
United States, Florida
St. Vincent's Medical Center
Jacksonville, Florida, United States, 32204
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611-3078
University of Chicago
Chicago, Illinois, United States, 60637-1470
Neurologic Associates Inc
Palos Heights, Illinois, United States, 60463
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Southern Illinois University Neurology
Springfield, Illinois, United States, 62702
United States, Indiana
Indiana Heart Physicians
Indianapolis, Indiana, United States, 46237
United States, Iowa
Ruan Neurology
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Midatlantic Cardiovascular Associates
Towson, Maryland, United States, 21014
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-0316
United States, Minnesota
St. Mary's Duluth Clinic
Duluth, Minnesota, United States, 55805
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Methodist Hospital/Park Nicollet Medical Center
Saint Louis Park, Minnesota, United States, 55426
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2045
United States, New Jersey
Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey, United States, 08034
University of Medicine and Dentistry of New Jersy
Newark, New Jersey, United States, 07103
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
DENT Neurologic Institute
Amherst, New York, United States, 14226
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27410
United States, Ohio
Neurology and Neuroscience Associates
Akron, Ohio, United States, 44320
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Providence St. Vincent's Medical Center
Portland, Oregon, United States, 97225
Oregon Stroke Center, OHSU
Portland, Oregon, United States, 97329
United States, Pennsylvania
LeHigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Penn State Milton South Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17543
St. Mary's Medical Center
Langhorne, Pennsylvania, United States, 19067
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
North Central Heart Institute
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
St. Thomas Neurology
Nashville, Tennessee, United States, 37205
Vanderbilt University
Nashville, Tennessee, United States, 37232-8802
United States, Texas
UT Southwestern Medical School
Dallas, Texas, United States, 75390-8897
University of Texas Houston Health Science Center
Houston, Texas, United States, 77030
United States, Virginia
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States, 23454
United States, Washington
UW Medicine Stroke Center
Seattle, Washington, United States, 98104
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W5
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
St. Paul's Hospital
Vancouver, British Columbia, Canada, V5Z 1Y6
Canada, Ontario
Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute
London, Ontario, Canada, N6G 2V2
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Abbott Medical Devices
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Principal Investigator: Jeffrey Saver, MD UCLA Stroke Center
Principal Investigator: John D Carroll, MD University of Colorado, Denver
Principal Investigator: Richard Smalling, MD University of Texas Houston Health Science Center
Principal Investigator: David Thaler, MD Tufts Medical Center
Additional Information:
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00465270    
Other Study ID Numbers: AGA-006
First Posted: April 24, 2007    Key Record Dates
Results First Posted: September 4, 2018
Last Update Posted: February 18, 2019
Last Verified: January 2019
Keywords provided by Abbott Medical Devices:
Patent foramen ovale
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases