N/A
Completed N=980
Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
Source: ClinicalTrials.gov NCT00465270 ↗Enrolled (actual)
980
Serious AEs
38.2%
Results posted
Sep 2018
Primary outcomePrimary: Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization — 9; 16 Participants — p=0.08
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization |
9; 16 | 0.08 |
| SECONDARY Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group |
249 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00465270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.