Atrial Fibrillation After PFO Closure
Condition: Stroke
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      An increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was
      observed in randomized trials but systematic screening of AF was not performed in these
      studies. Purpose: The objective of this study was to evaluate incidence of AF in patients who
      underwent percutaneous PFO closure with serial 24-hours ambulatory ECG (AECG) monitoring
      during 6 months follow-up. Primary endpoint was incidence of AF on ECG monitoring. Secondary
      endpoints were clinical outcomes (symptoms, hospitalization from cardiovascular causes,
      ischemic stroke, or bleeding) up to 6 month follow-up.
    

Detailed description: 
      This is a prospective, bicentric, observational cohort study which will be performed in
      University hospital center of Montpellier and Nîmes The study will include all consecutive
      patients, admitted for a percutaneous PFO closure after an ischemic stroke (IS) or a
      transient ischemic attack (TIA) of cryptogenic origin, or after the occurrence of a
      decompression illness during scuba diving. Patients eligible for the closure of a FOP in
      prevention of the recurrence of stroke or TIA of cryptogenic origin, was systematically
      evaluated for exclusion of supraventricular arrhythmia in accordance with international
      recommendations. This evaluation included a 12-lead ECG as well as an extended
      electrocardiographic monitoring lasting more than or equal to 24 hours (most frequently,
      performing a 72-hour ECG Holter). All patients previously has a transesophageal ultrasound
      (TEE) allowing to retain the diagnosis of PFO, to assess the presence or not of an atrial
      septum aneurysm (ASA) associated with PFO and to quantify the right to left shunt thanks to a
      contrast test potentiated by a Valsalva maneuver. Exclusion criteria included interatrial
      defect with left to right and others indications for PFO closure that cryptogenic stroke or
      decompression illness. Indication of PFO closure is always validated by a cardio neurological
      team.

      The primary objective of the study was incidence of AF defined as an irregular rhythm without
      discernible P waves lasting at least 30 seconds on ECG monitoring during the 6-month
      follow-up. The secondary objectives were to evaluate the characteristics of the
      supra-ventricular arrhythmias (delay in onset, duration, recurrent nature), incidence of
      others arrhythmia, symptoms, and prognostic implications of AF (hospitalization , need of
      curative anticoagulation, need for cardioversion and occurrence of neurological accident
      documented by imagery (ischemic stroke or TIA). The investigators also evaluated risk factors
      for occurrence of arrhythmia.

      A total of 100 patients included during 1 year is expected
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient at least 18 years old, benefiting from percutaneous closure of the FOP after a
        cryptogenic stroke (indication validated during a multidisciplinary meeting with
        neurologists and cardiologists)
      
Keywords: Cryptogenic