Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study

Study Overview
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Brief Summary
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This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke.

Detailed Description
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This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale (PFO) for cryptogenic stroke. Secondary objectives include assessment of the burden of AF at 2, 12 and 24 months after PFO closure; evaluation of the relationship between plasma levels of MR proANP and presence of AF within 2 years after percutaneous PFO closure in patients with a history of cryptogenic ischemic stroke; and description of recurrence rates for stroke (ischemic and hemorrhagic), major bleeding, minor bleeding, peripheral emboli during the 2-year follow-up period after percutaneous PFO closure, in patients with and without AF.

Official Title
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Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study

Conditions
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Patent Foramen Ovale, Atrial Fibrillation, Stroke

Intervention / Treatment
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* Device: Implantation of Holter device
* Procedure: Percutaneous PFO closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (aged >18 years) with an indication for percutaneous closure of PFO due to cryptogenic stroke, with indication validated by a cardio-neurological team. patients must provide written informed consent patients must be affiliated to a social security regime or be a beneficiary thereof. Exclusion Criteria: Patients under legal protection Patients not affiliated to any social security regime Patients within the exclusion period of another clinical trial as per the national registry of research volunteers

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients planned for percutaneous PFO closure<br>Patients will undergo implantation of a Holter device (Reveal Linq Medtronic) 2 months prior to percutaneous PFO closure. Devices will be monitored by telemonitoring until the PFO closure procedure, and at 2, 12 and 24 months after the procedure. | Device: Implantation of Holter device<br>* Implantation of a Holter device (Reveal Linq, Medtronic) for telemonitoring of cardiac rhythm<br>Procedure: Percutaneous PFO closure<br>* Patients will undergo percutaneous closure of patent foramen ovale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation | Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds) | Within 2 months after percutaneous PFO closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation | Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds) | Within 24 months after percutaneous PFO closure | 
| Burden of atrial fibrillation | Cumulative total time in atrial fibrillation (in days, hours, minutes) | Within 2 years after percutaneous PFO closure | 
| Relation between MR proANP levels and atrial fibrillation | Relation between pre-procedure circulating venous MR proANP levels and atrial fibrillation defined as per the primary endpoint | Within 2 years after percutaneous PFO closure | 
| Stroke | Ischemic or hemorrhagic stroke documented by CT or MRI | Within 2 years after percutaneous PFO closure | 
| Peripheral emboli | Peripheral emboli by CT or MRI | Within 2 years after percutaneous PFO closure | 
| Bleeding | Major or minor bleeding according to the ISTH classification | Within 2 years after percutaneous PFO closure |