Atrial Fibrillation After PFO Closure

Completed

• Conditions: Stroke

• Registration Number: NCT04290052
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Study Start: 2020-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2022-01-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
occurrence of sustained supra-ventricular arrhythmia	at 12 month	occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 12 month (Holter ECG)

Secondary Outcome Measures

Name	Time	Method
hospitalization related to arrhythmia	24 hours post-intervention to 12 months	hospitalization related to arrhythmia
symptoms related to the arrhythmia episode	24 hours post-intervention to 12 months	symptoms related to the arrhythmia episode
characteristics of these detected arrhythmias	24 hours post-intervention to 12 months	characteristics of these detected arrhythmias : recurrence
occurrence of a neurological accident.	24 hours post-intervention to 12 months	occurrence of a neurological accident.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France