Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment

Coronary Artery Disease - RESPECT PFO

Trial Sponsor
AGA Medical Corporation

Principal Investigator
Joni Clark, MD / Tony DeMartini, MD

Trial Name
Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment

Purpose
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.

Phase
Phase II

Study Type
Interventional

Study Design
Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Expected Enrollment
500

Study Start
August 2003

Eligibility

Ages Eligible for Study
18 – 60 Years

Genders Eligible for Study
Both

Inclusion Criteria

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 Criteria

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

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