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

Completed · Not applicable

Conditions studied: Cryptogenic Stroke

In brief

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.

Key facts

Study ID

NCT00465270

Run by

Abbott Medical Devices

People needed

980

Starts

2003-08-01

Expected to finish

2016-05-01

Last updated by the study team

2019-02-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Sharp Memorial Hospital — San Diego, California, United States
• Kaiser Permanente — San Francisco, California, United States
• University of Colorado — Denver, Colorado, United States
• South Denver Cardiology Associates — Littleton, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• St. Vincent's Medical Center — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Neurologic Associates Inc — Palos Heights, Illinois, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Southern Illinois University Neurology — Springfield, Illinois, United States
• Indiana Heart Physicians — Indianapolis, Indiana, United States
• Ruan Neurology — Des Moines, Iowa, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Midatlantic Cardiovascular Associates — Towson, Maryland, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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