Clinical trial NCT04926142: Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study
Official title: Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Patent Foramen Ovale
Atrial Fibrillation
Stroke
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective patients who have had cryptogenic stroke (ischemic only) and with patent foramen ovale confirmed by transoesophageal echocardiography, with an indication for percutaneous closure.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Atrial fibrillation
timeFrame: Within 2 months after percutaneous PFO closure
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: Within 24 months after percutaneous PFO closure
measure: Burden of atrial fibrillation
timeFrame: Within 2 years after percutaneous PFO closure
measure: Relation between MR proANP levels and atrial fibrillation
timeFrame: Within 2 years after percutaneous PFO closure
measure: Stroke
timeFrame: Within 2 years after percutaneous PFO closure
measure: Peripheral emboli
timeFrame: Within 2 years after percutaneous PFO closure
measure: Bleeding
timeFrame: Within 2 years after percutaneous PFO closure
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital Besancon
city: Bron
country: France
facility: CHU Lyon - Hôpital Louis Pradel
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Grenoble
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Marc Badoz, MD
role: PRINCIPAL_INVESTIGATOR
References: