Last reviewed · How we verify

NCT04290052: AFEPFO

Atrial Fibrillation After PFO Closure

Completed Last updated 14 April 2022
What this trial tests

trial in Stroke in 100 participants. Completed in 1 January 2022.

Timeline
1 March 2020
Primary endpoint
1 March 2021
1 January 2022

Quick facts

Lead sponsorUniversity Hospital, Montpellier
StatusCompleted
Study typeOBSERVATIONAL
Enrollment100
Start date1 March 2020
Primary completion1 March 2021
Estimated completion1 January 2022
Sites1 location across France

Conditions studied

Sponsor

University Hospital, Montpellier

Who can join

Adults 18 to 60, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Atrial fibrillation screening on systematic ambulatory electrocardiogram monitoring after percutaneous patent foramen ovale closure: A prospective study.
    Leclercq F, Odorico X, Marin G, Christophe Macia J, et al · · 2021 · cited 8× · PMID 34849392 · DOI 10.1016/j.ijcha.2021.100919

Verify or expand the search:

Other recruiting trials for Stroke

Currently open trials in the same condition.

Other University Hospital, Montpellier trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04290052.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing