Atrial Fibrillation After PFO Closure

Stroke Clinical Trial

— AFEPFO  

Official title:

Atrial Fibrillation on Holter Monitoring After Percutaneous Patent Foramen Ovale Closure : a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290052
• Other study ID #: RECHMPL19_0517
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials but systematic screening of AF was not performed in these studies. Purpose: The objective of this study was to evaluate incidence of AF in patients who underwent percutaneous PFO closure with serial 24-hours ambulatory ECG (AECG) monitoring during 6 months follow-up. Primary endpoint was incidence of AF on ECG monitoring. Secondary endpoints were clinical outcomes (symptoms, hospitalization from cardiovascular causes, ischemic stroke, or bleeding) up to 6 month follow-up.

Description:

This is a prospective, bicentric, observational cohort study which will be performed in University hospital center of Montpellier and Nîmes The study will include all consecutive patients, admitted for a percutaneous PFO closure after an ischemic stroke (IS) or a transient ischemic attack (TIA) of cryptogenic origin, or after the occurrence of a decompression illness during scuba diving. Patients eligible for the closure of a FOP in prevention of the recurrence of stroke or TIA of cryptogenic origin, was systematically evaluated for exclusion of supraventricular arrhythmia in accordance with international recommendations. This evaluation included a 12-lead ECG as well as an extended electrocardiographic monitoring lasting more than or equal to 24 hours (most frequently, performing a 72-hour ECG Holter). All patients previously has a transesophageal ultrasound (TEE) allowing to retain the diagnosis of PFO, to assess the presence or not of an atrial septum aneurysm (ASA) associated with PFO and to quantify the right to left shunt thanks to a contrast test potentiated by a Valsalva maneuver. Exclusion criteria included interatrial defect with left to right and others indications for PFO closure that cryptogenic stroke or decompression illness. Indication of PFO closure is always validated by a cardio neurological team.

The primary objective of the study was incidence of AF defined as an irregular rhythm without discernible P waves lasting at least 30 seconds on ECG monitoring during the 6-month follow-up. The secondary objectives were to evaluate the characteristics of the supra-ventricular arrhythmias (delay in onset, duration, recurrent nature), incidence of others arrhythmia, symptoms, and prognostic implications of AF (hospitalization , need of curative anticoagulation, need for cardioversion and occurrence of neurological accident documented by imagery (ischemic stroke or TIA). The investigators also evaluated risk factors for occurrence of arrhythmia.

A total of 100 patients included during 1 year is expected

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2022
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Men or women over the age of 18 to 60

• Benefiting from the closure of the FOP percutaneously after a cryptogenic ischemic stroke or a TIA (indication validated during a multidisciplinary meeting with neurologists and cardiologists)

Exclusion Criteria:

• Inability to perform a 24h ECG Holter

• Pregnant or lactating women

• Vulnerable people

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of sustained supra-ventricular arrhythmia	occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis the 24-hour Holter ECG performed post-intervention	the 24-hour post-intervention
Primary	occurrence of sustained supra-ventricular arrhythmia	occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 1 month (Holter ECG)	at 1 month
Primary	occurrence of sustained supra-ventricular arrhythmia	occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 6 month (Holter ECG)	at 6 month
Primary	occurrence of sustained supra-ventricular arrhythmia	occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 12 month (Holter ECG)	at 12 month
Secondary	characteristics of these detected arrhythmias	characteristics of these detected arrhythmias : time to onset	24 hours post-intervention to 12 months
Secondary	characteristics of these detected arrhythmias	characteristics of these detected arrhythmias : duration	24 hours post-intervention to 12 months
Secondary	characteristics of these detected arrhythmias	characteristics of these detected arrhythmias : recurrence	24 hours post-intervention to 12 months
Secondary	symptoms related to the arrhythmia episode	symptoms related to the arrhythmia episode	24 hours post-intervention to 12 months
Secondary	hospitalization related to arrhythmia	hospitalization related to arrhythmia	24 hours post-intervention to 12 months
Secondary	occurrence of a neurological accident.	occurrence of a neurological accident.	24 hours post-intervention to 12 months