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

Centre Hospitalier Universitaire de Besancon

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Stroke; Patent Foramen Ovale

Treatments: Device: Implantation of Holter device; Procedure: Percutaneous PFO closure

Study type: Observational

Funder types: Other

Identifiers

NCT04926142

2020-A03417-32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Patients planned for percutaneous PFO closure

Description:

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.

Treatment:

Device: Implantation of Holter device

Procedure: Percutaneous PFO closure