Atrial Fibrillation After PFO Closure

NCT04290052 | Completed

• 1 other identifier: RECHMPL19_0517
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Cryptogenic

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• characteristics of these detected arrhythmias

  24 hours post-intervention to 12 months

• characteristics of these detected arrhythmias

  24 hours post-intervention to 12 months

• characteristics of these detected arrhythmias

  24 hours post-intervention to 12 months

• symptoms related to the arrhythmia episode

  24 hours post-intervention to 12 months

• hospitalization related to arrhythmia

  24 hours post-intervention to 12 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient at least 18 years old, benefiting from percutaneous closure of the FOP after a cryptogenic stroke (indication validated during a multidisciplinary meeting with neurologists and cardiologists)

You may qualify if:

• 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)

You may not qualify if:

• Inability to perform a 24h ECG Holter
• Pregnant or lactating women
• Vulnerable people

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Florence Leclercq, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 28, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: January 1, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

FR (1)