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RESPECT PFO Clinical Trial

Information source: St. Jude Medical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cryptogenic Stroke

Intervention: AMPLATZER PFO Occluder (Device); Standard of Care - Medical Management (Other)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: St. Jude Medical

Official(s) and/or principal investigator(s):
Jeffrey Saver, MD, Principal Investigator, Affiliation: UCLA Stroke Center
John D Carroll, MD, Principal Investigator, Affiliation: University of Colorado, Denver
Richard Smalling, MD, Principal Investigator, Affiliation: University of Texas Houston Health Science Center
David Thaler, MD, Principal Investigator, Affiliation: Tufts Medical Center

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.

Clinical Details

Official title: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Recurrence of nonfatal stroke

Secondary outcome: Complete closure of the defect demonstrated by TEE and bubble study (device group).

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

University of Alabama, Birmingham, Alabama 35249, United States

University of Calgary, Calgary, Alberta T2N 2T9, Canada

University of Alberta, Edmonton, Alberta T6G 2B7, Canada

Mayo Clinic, Scottsdale, Arizona 85259, United States

Royal Columbian Hospital, New Westminster, British Columbia V3L 3W5, Canada

St. Paul's Hospital, Vancouver, British Columbia V5Z 1Y6, Canada

Vancouver General Hospital, Vancouver, British Columbia V5Z 1M9, Canada

LAC + USC Medical Center, Los Angeles, California 90033, United States

UCLA, Los Angeles, California 90095, United States

Summit Medical Center, Oakland, California 94609, United States

Sharp Memorial Hospital, San Diego, California 92123, United States

Kaiser Permanente, San Francisco, California 94115, United States

University of Colorado, Denver, Colorado 80262, United States

South Denver Cardiology Associates, Littleton, Colorado 80120, United States

Medical Center of the Rockies, Loveland, Colorado 80538, United States

George Washington University Hospital, Washington, District of Columbia 20037, United States

Washington Hospital Center, Washington, District of Columbia 20010, United States

St. Vincent's Medical Center, Jacksonville, Florida 32204, United States

Northwestern University, Chicago, Illinois 60611-3078, United States

University of Chicago, Chicago, Illinois 60637-1470, United States

Neurologic Associates Inc, Palos Heights, Illinois 60463, United States

OSF St. Francis Medical Center, Peoria, Illinois 61637, United States

Southern Illinois University Neurology, Springfield, Illinois 62702, United States

Indiana Heart Physicians, Indianapolis, Indiana 46237, United States

Ruan Neurology, Des Moines, Iowa 50314, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

Kansas University Medical Center, Kansas City, Kansas 66160, United States

University of Kentucky, Lexington, Kentucky 40536, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Midatlantic Cardiovascular Associates, Towson, Maryland 21014, United States

Tufts Medical Center, Boston, Massachusetts 02111, United States

University of Michigan Health System, Ann Arbor, Michigan 48109-0316, United States

St. Mary's Duluth Clinic, Duluth, Minnesota 55805, United States

Abbott Northwestern Hospital, Minneapolis, Minnesota 55407, United States

University of Minnesota, Minneapolis, Minnesota 55455, United States

Methodist Hospital/Park Nicollet Medical Center, St. Louis Park, Minnesota 55426, United States

Washington University, St. Louis, Missouri 63110, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-2045, United States

Our Lady of Lourdes Medical Center, Cherry Hill, New Jersey 08034, United States

University of Medicine and Dentistry of New Jersy, Newark, New Jersey 07103, United States

Albany Medical Center, Albany, New York 12208, United States

DENT Neurologic Institute, Amherst, New York 14226, United States

University of Rochester, Rochester, New York 14642, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Moses H. Cone Memorial Hospital, Greensboro, North Carolina 27410, United States

Neurology and Neuroscience Associates, Akron, Ohio 44320, United States

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

Ohio State University, Columbus, Ohio 43210, United States

Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute, London, Ontario N6G 2V2, Canada

Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada

Oregon Stroke Center, OHSU, Portland, Oregon 97329, United States

Providence St. Vincent's Medical Center, Portland, Oregon 97225, United States

LeHigh Valley Hospital, Allentown, Pennsylvania 18105, United States

Penn State Milton South Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Lancaster General Hospital, Lancaster, Pennsylvania 17543, United States

St. Mary's Medical Center, Langhorne, Pennsylvania 19067, United States

Montreal Heart Institute, Montreal, Quebec H1T 1C8, Canada

Medical University of South Carolina, Charleston, South Carolina 29425, United States

North Central Heart Institute, Sioux Falls, South Dakota 57108, United States

St. Thomas Neurology, Nashville, Tennessee 37205, United States

Vanderbilt University, Nashville, Tennessee 37232-8802, United States

UT Southwestern Medical School, Dallas, Texas 75390-8897, United States

University of Texas Houston Health Science Center, Houston, Texas 77030, United States

Sentara Virginia Beach General Hospital, Virginia Beach, Virginia 23454, United States

UW Medicine Stroke Center, Seattle, Washington 98104, United States

Charleston Area Medical Center, Charleston, West Virginia 25304, United States

University of Wisconsin Hospital, Madison, Wisconsin 53792, United States

Marshfield Clinic, Marshfield, Wisconsin 54449, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: August 2003
Last updated: April 22, 2015

Page last updated: August 23, 2015

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