RESPECT PFO Clinical Trial - Full Text View

Purpose

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	Intervention	Phase
Cryptogenic Stroke	Device: AMPLATZER PFO Occluder Other: Standard of Care - Medical Management	Phase 2

AGA Medical Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment

Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:

Recurrence of nonfatal stroke [ Time Frame: Annually until approved ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete closure of the defect demonstrated by TEE and bubble study (device group). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	August 2003
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AMPLATZER PFO Occluder	Device: AMPLATZER PFO Occluder patent foramen ovale closure device
Active Comparator: 2 Medical Management	Other: Standard of Care - Medical Management Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465270

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Locations

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
UCLA
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
University of Chicago
Chicago, Illinois, United States, 60637-1470
Northwestern University
Chicago, Illinois, United States, 60611-3078
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
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Methodist Hospital/Park Nicollet Medical Center
St. Louis Park, Minnesota, United States, 55426
United States, Missouri
Washington University
St. 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
Oregon Stroke Center, OHSU
Portland, Oregon, United States, 97329
Providence St. Vincent's Medical Center
Portland, Oregon, United States, 97225
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
St. Paul's Hospital
Vancouver, British Columbia, Canada, V5Z 1Y6
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
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

AGA Medical Corporation

Investigators

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by AGA Medical Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	AGA Medical Corporation
ClinicalTrials.gov Identifier:	NCT00465270 History of Changes
Other Study ID Numbers:	AGA-006, G990318
Study First Received:	April 23, 2007
Last Updated:	May 15, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:

Cryptogenic
Stroke
PFO

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on June 17, 2013