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Lead
Abbott Medical Devices
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.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
