Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
- Conditions
- Cryptogenic Stroke
- 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
- 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 Alabama
🇺🇸Birmingham, Alabama, 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
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
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