NCT04926142

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Foramen Ovale
• Atrial Fibrillation
• Stroke

Interventions

Type	Name	Description
DEVICE	Implantation of Holter device	Implantation of a Holter device (Reveal Linq, Medtronic) for telemonitoring of cardiac rhythm
PROCEDURE	Percutaneous PFO closure	Patients will undergo percutaneous closure of patent foramen ovale

Timeline

• Start date: 2021-07-05
• Primary completion: 2025-08-21
• Completion: 2025-12-31
• First posted: 2021-06-14
• Last updated: 2024-02-01

Locations

4 sites across 1 country: France