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

Stroke Clinical Trial

— PFO-AF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04926142
• Other study ID #: 2020-A03417-32
• Status: Active, not recruiting
• Start date: July 5, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 31, 2025
• Est. primary completion date: August 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Foramen Ovale, Patent
• Ischemic Stroke
• Patent Foramen Ovale
• Stroke

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Besancon	Besançon
France	CHU Lyon - Hôpital Louis Pradel	Bron
France	CHU Dijon	Dijon
France	CHU Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

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