Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale

Study Overview
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Brief Summary
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Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism. After the PFO closure procedure a dual antiplatelet regimen is often prescribed for 3-6 months and several cardiologic and neurologic follow-up exams are scheduled in the first 12 months of follow-up. Usually a transthoracic +/- transoesophageal echocardiography (TTE +/- TEE) are performed at 6 months, however this kind of control is not systematically performed. In order to improve the clinical outcomes in this young patients' population, the investigators prospectively perform a complete cardiologic and neurologic follow-up program to all patients undergoing a successful percutaneous closure of a PFO. The aim of these controls is to confirm the good position of the PFO-device, to confirm the absence of any residual right to left shunt or any significant atrial arrhythmias Furthermore this prospective follow-up will analyze the possible mechanisms leading to a cerebral stroke recurrence (e.g. size of the PFO, presence of an atrial septal aneurysm, presence of a residual shunt, size of the utilized closure device, ....).

Detailed Description
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At follow-up the following exams will be performed: at hospital discharge: chest X-ray +/- TTE + 7-days event loop record (ELR) at 6 months: clinical cardiologic and neurologic examination + TTE + TEE + 7-days ELR + trans-cranial doppler (TCD) with micro bubbles detection. at 1 year: clinical cardiologic and neurologic examination + TTE +/- TEE + 7-days ELR + trans-cranial doppler (TCD) with micro bubbles detection +/- cerebral MRI

Official Title
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Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale

Conditions
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Stroke, Foramen Ovale, Patent

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old patients signed informed consent all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke Exclusion Criteria: all patients with an alternative aetiology of the initial stroke all patients in whom the percutaneous closure of the PFO is contraindicated all patients with a known allergy to aspirin and or clopidogrel

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual shunt at 6-12 months follow-up | incidence and clinical relevance of right to left residual shunts at 6-12 months after the successful closure of the PFO | 6-12 months | 
| stroke recurrence | incidence and clinical predictors of stroke recurrence at 6-12 months | 6-12 months | 
| possible other aetiologies of the initial cryptogenic stroke | during the 12 months follow-up all other possible aetiologies explaining the initial cryptogenic stroke will be taken into consideration | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 months dual antiplatelet regimen safety and efficacy | confirm the safety and efficacy of the adopted 6 months dual antiplatelet regimen | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryptogenic stroke, percutaneous closure of PFO, follow-up exams