Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/20/2019 |
| Start Date: | August 2003 |
| End Date: | May 2016 |
Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
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.
closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical
treatment in the prevention of recurrent embolic stroke.
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.
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.
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
We found this trial at
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
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Charleston, South Carolina 29425
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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