Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
- Conditions
- Cryptogenic Stroke
- Interventions
- Other: Standard of Care - Medical ManagementDevice: AMPLATZER PFO Occluder
- Registration Number
- NCT00465270
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 980
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard or Care - Medical Management Standard of Care - Medical Management Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole. Device AMPLATZER PFO Occluder AMPLATZER PFO Occluder
- Primary Outcome Measures
Name Time Method Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization 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
Name Time Method Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group 6 months
Trial Locations
- Locations (69)
University of Chicago
🇺🇸Chicago, Illinois, United States
UW Medicine Stroke Center
🇺🇸Seattle, Washington, 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
South Denver Cardiology Associates
🇺🇸Littleton, Colorado, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Neurologic Associates Inc
🇺🇸Palos Heights, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Ruan Neurology
🇺🇸Des Moines, Iowa, United States
Southern Illinois University Neurology
🇺🇸Springfield, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Midatlantic Cardiovascular Associates
🇺🇸Towson, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
St. Mary's Duluth Clinic
🇺🇸Duluth, Minnesota, United States
Methodist Hospital/Park Nicollet Medical Center
🇺🇸Saint Louis Park, Minnesota, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
DENT Neurologic Institute
🇺🇸Amherst, New York, United States
Our Lady of Lourdes Medical Center
🇺🇸Cherry Hill, New Jersey, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Moses H. Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Neurology and Neuroscience Associates
🇺🇸Akron, Ohio, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, 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
UT Southwestern Medical School
🇺🇸Dallas, Texas, United States
Sentara Virginia Beach General Hospital
🇺🇸Virginia Beach, Virginia, United States
University of Texas Houston Health Science Center
🇺🇸Houston, Texas, 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
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, 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
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Indiana Heart Physicians
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Kaiser Permanente
🇺🇸San Francisco, California, United States
St. Thomas Neurology
🇺🇸Nashville, Tennessee, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
University of Rochester
🇺🇸Rochester, New York, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Oregon Stroke Center, OHSU
🇺🇸Portland, Oregon, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
University of Colorado
🇺🇸Denver, Colorado, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Providence St. Vincent's Medical Center
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Medicine and Dentistry of New Jersy
🇺🇸Newark, New Jersey, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
St. Vincent's Medical Center
🇺🇸Jacksonville, Florida, United States
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada