Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)

Conditions
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Cryptogenic Stroke

Intervention / Treatment
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* Device: AMPLATZER PFO Occluder
* Other: Standard of Care - Medical Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: AMPLATZER PFO Occluder
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>AMPLATZER PFO Occluder | Device: AMPLATZER PFO Occluder<br>* patent foramen ovale closure device<br>|
| Active Comparator: Standard or Care - Medical Management<br>Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole. | Other: Standard of Care - Medical Management<br>* Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization | Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last. | Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryptogenic, Stroke, PFO, Patent foramen ovale, AMPLATZER, Occluder