Status:
COMPLETED
Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cryptogenic Stroke
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
980 Patients enrolled
Trial Details
Trial ID
NCT00465270
Start Date
August 1 2003
End Date
May 1 2016
Last Update
February 18 2019
Active Locations (69)
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1
University of Alabama
Birmingham, Alabama, United States, 35249
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
LAC + USC Medical Center
Los Angeles, California, United States, 90033
4
UCLA
Los Angeles, California, United States, 90095