Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
Launched by ABBOTT MEDICAL DEVICES · Apr 23, 2007
Trial Information
Current as of June 08, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility 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
About Abbott Medical Devices
Abbott Medical Devices is a leading global healthcare company dedicated to advancing medical technology through innovative research and development. With a robust portfolio of diagnostic, therapeutic, and monitoring solutions, Abbott is committed to improving patient outcomes and enhancing the quality of care across various medical fields. The company places a strong emphasis on clinical trials to validate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals. By leveraging cutting-edge science and technology, Abbott Medical Devices aims to address pressing health challenges and deliver transformative solutions that empower patients and healthcare providers alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Minneapolis, Minnesota, United States
Columbus, Ohio, United States
Durham, North Carolina, United States
Marshfield, Wisconsin, United States
Lexington, Kentucky, United States
Cleveland, Ohio, United States
Milwaukee, Wisconsin, United States
Charleston, South Carolina, United States
Chicago, Illinois, United States
Nashville, Tennessee, United States
Toronto, Ontario, Canada
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Allentown, Pennsylvania, United States
Oakland, California, United States
Peoria, Illinois, United States
Washington, District Of Columbia, United States
San Diego, California, United States
Washington, District Of Columbia, United States
Scottsdale, Arizona, United States
Rochester, New York, United States
Denver, Colorado, United States
Boston, Massachusetts, United States
Omaha, Nebraska, United States
Saint Louis, Missouri, United States
Albany, New York, United States
Los Angeles, California, United States
Kansas City, Kansas, United States
Ann Arbor, Michigan, United States
Los Angeles, California, United States
Montreal, Quebec, Canada
Madison, Wisconsin, United States
Minneapolis, Minnesota, United States
Vancouver, British Columbia, Canada
Jacksonville, Florida, United States
Duluth, Minnesota, United States
Chicago, Illinois, United States
Birmingham, Alabama, United States
Edmonton, Alberta, Canada
Amherst, New York, United States
Virginia Beach, Virginia, United States
Des Moines, Iowa, United States
Sioux Falls, South Dakota, United States
San Francisco, California, United States
Indianapolis, Indiana, United States
Littleton, Colorado, United States
Calgary, Alberta, Canada
Charleston, West Virginia, United States
Towson, Maryland, United States
Loveland, Colorado, United States
Palos Heights, Illinois, United States
Springfield, Illinois, United States
Saint Louis Park, Minnesota, United States
Cherry Hill, New Jersey, United States
Newark, New Jersey, United States
Greensboro, North Carolina, United States
Akron, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Seattle, Washington, United States
New Westminster, British Columbia, Canada
Vancouver, British Columbia, Canada
London, Ontario, Canada
Patients applied
Trial Officials
Jeffrey Saver, MD
Principal Investigator
UCLA Stroke Center
John D Carroll, MD
Principal Investigator
University of Colorado, Denver
Richard Smalling, MD
Principal Investigator
University of Texas Houston Health Science Center
David Thaler, MD
Principal Investigator
Tufts Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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