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

Active, not recruiting

• Conditions: Stroke; Atrial Fibrillation; Patent Foramen Ovale
• Interventions: Device: Implantation of Holter device; Procedure: Percutaneous PFO closure

• Registration Number: NCT04926142
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-11
• Study First Posted: 2021-06-14
• Study Start: 2021-07-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-08-21
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients planned for percutaneous PFO closure	Implantation of Holter device	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.
Patients planned for percutaneous PFO closure	Percutaneous PFO closure	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.

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	Within 2 months after percutaneous PFO closure	Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds)

Secondary Outcome Measures

Name	Time	Method
Atrial fibrillation	Within 24 months after percutaneous PFO closure	Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds)
Burden of atrial fibrillation	Within 2 years after percutaneous PFO closure	Cumulative total time in atrial fibrillation (in days, hours, minutes)
Relation between MR proANP levels and atrial fibrillation	Within 2 years after percutaneous PFO closure	Relation between pre-procedure circulating venous MR proANP levels and atrial fibrillation defined as per the primary endpoint
Stroke	Within 2 years after percutaneous PFO closure	Ischemic or hemorrhagic stroke documented by CT or MRI
Bleeding	Within 2 years after percutaneous PFO closure	Major or minor bleeding according to the ISTH classification
Peripheral emboli	Within 2 years after percutaneous PFO closure	Peripheral emboli by CT or MRI

Trial Locations

Locations (4)

University Hospital Besancon; 🇫🇷 Besançon, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Lyon - Hôpital Louis Pradel; 🇫🇷 Bron, France

CHU Grenoble; 🇫🇷 Grenoble, France