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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Atrial Fibrillation; Patent Foramen Ovale
• Intervention / Treatment: Device: Implantation of Holter device; Procedure: Percutaneous PFO closure

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 Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

• Study Contact: Name: Marc Badoz, MD; Phone Number: 33381668185; Email: mbadoz@chu-besancon.fr
• Study Contact Backup: Name: Marie-Line Perruche; Phone Number: 33381669434

Study Locations

• France
  • Besançon, France, 25000
    • University Hospital Besancon
  • Bron, France
    • CHU Lyon - Hôpital Louis Pradel
  • Dijon, France
    • CHU Dijon
  • Grenoble, France
    • Chu Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients planned for 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.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds)	Within 24 months after percutaneous PFO closure
Burden of atrial fibrillation	Cumulative total time in atrial fibrillation (in days, hours, minutes)	Within 2 years after percutaneous PFO closure
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
Stroke	Ischemic or hemorrhagic stroke documented by CT or MRI	Within 2 years after percutaneous PFO closure
Peripheral emboli	Peripheral emboli by CT or MRI	Within 2 years after percutaneous PFO closure
Bleeding	Major or minor bleeding according to the ISTH classification	Within 2 years after percutaneous PFO closure

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Marc Badoz, MD, Centre Hospitalier Universitaire de Besançon

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Estimated): August 21, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Arrhythmias, Cardiac; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Stroke; Ischemic Stroke; Atrial Fibrillation; Foramen Ovale, Patent
• Other Study ID Numbers: 2020-A03417-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No