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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients planned for percutaneous PFO closure | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of Holter device | Device | Implantation of a Holter device (Reveal Linq, Medtronic) for telemonitoring of cardiac rhythm |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Prospective patients who have had cryptogenic stroke (ischemic only) and with patent foramen ovale confirmed by transoesophageal echocardiography, with an indication for percutaneous closure.
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| Name | Affiliation | Role |
|---|---|---|
| Marc Badoz, MD | Centre Hospitalier Universitaire de Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Besancon | Besançon | 25000 | France | |||
| CHU Lyon - Hôpital Louis Pradel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37699623 | Derived | Badoz M, Derimay F, Serzian G, Besutti M, Rioufol G, Frey P, Guenancia C, Ecarnot F, Meneveau N, Chopard R. Incidence of atrial fibrillation in cryptogenic stroke with patent foramen ovale closure: protocol for the prospective, observational PFO-AF study. BMJ Open. 2023 Sep 12;13(9):e074584. doi: 10.1136/bmjopen-2023-074584. |
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| Percutaneous PFO closure | Procedure | Patients will undergo percutaneous closure of patent foramen ovale |
|
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 |
| Bron |
| France |
| CHU Dijon | Dijon | France |
| CHU Grenoble | Grenoble | France |
| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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