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.
Study Type
OBSERVATIONAL
Enrollment
250
Implantation of a Holter device (Reveal Linq, Medtronic) for telemonitoring of cardiac rhythm
Patients will undergo percutaneous closure of patent foramen ovale
University Hospital Besancon
Besançon, France
CHU Lyon - Hôpital Louis Pradel
Bron, France
CHU Dijon
Dijon, France
CHU Grenoble
Grenoble, France
Atrial fibrillation
Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds)
Time frame: Within 2 months after percutaneous PFO closure
Atrial fibrillation
Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds)
Time frame: Within 24 months after percutaneous PFO closure
Burden of atrial fibrillation
Cumulative total time in atrial fibrillation (in days, hours, minutes)
Time frame: 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
Time frame: Within 2 years after percutaneous PFO closure
Stroke
Ischemic or hemorrhagic stroke documented by CT or MRI
Time frame: Within 2 years after percutaneous PFO closure
Peripheral emboli
Peripheral emboli by CT or MRI
Time frame: Within 2 years after percutaneous PFO closure
Bleeding
Major or minor bleeding according to the ISTH classification
Time frame: Within 2 years after percutaneous PFO closure
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