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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    250
  • sponsor
    Centre Hospitalier Universitaire de Besancon
Updated on 12 August 2021
stroke
holter monitor
fibrillation

Summary

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.

Description

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.

Details
Condition Atrial Fibrillation (Pediatric), Atrial Fibrillation, Dysrhythmia, Stroke, Patent foramen ovale, Cerebrovascular accident, cerebrovascular accidents, ostium secundum atrial septal defect, Arrhythmia, strokes, cerebral
Treatment Implantation of Holter device, Percutaneous PFO closure
Clinical Study IdentifierNCT04926142
SponsorCentre Hospitalier Universitaire de Besancon
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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