Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

NCT05213104 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 3

Started

2022-03-23

Last updated

2026-09-09

Condition(s) studied

Patent Foramen OvaleAtrial ArrhythmiaCryptogenic Stroke

Investigational drug(s) / intervention(s)

Flecainide →Flecainide →

Flecainide: Flecainide 150 mg 6 months in addition to standard of care

Flecainide: Flecainide 150 mg 3 months in addition to standard of care

Study summary

About 30% of ischemic strokes are cryptogenic. Patent Foramen Ovale (PFO) is present in about 25% of the general population. In cryptogenic strokes, PFO has been shown to be overrepresented and recent intervention studies have confirmed that PFO has a causal link with stroke. In patients with recent cryptogenic stroke, these randomized studies have shown at least 50%-reduction of recurrent neurological events after PFO percutaneous closure compared with medical therapy alone. At the The risk of AF reported in these studies in certainly largely underestimated as only symptomatic and recorded episodes of AF have been declared. Patients often report palpitations without a dia gnosis of AF made on the ECG or a Holter. Long term ECG monitoring provides more accurate data on AF incidence.

Administration of flecainide has been shown to be effective in preventing Atrial arrhythmia and may be useful in preventing these Atrial arrhythmia(AA) episodes after PFO closure.

To the knowledge of the investigators, there is no study assessing the efficacy of any antiarrhythmic drug in the prevention of AFafter PFO closure. AFLOAT will be the first randomized study to possibly validate flecainide to prevent Atrial arrhythmia in these patients.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * ≥ 18 years of age * They are candidates for a procedure of PFO closure, whatever the indication (secondary prevention of stroke, platypnoea, decompression illness…). The indication must have been confirmed by a multidisciplinary team as recommended by the Haute Autorité de Santé. * They are affiliated to Social Security * They have provided a signed written consent form ICM implantation and randomization will occur only in patients with successful PFO closure without any major complications Exclusion Criteria: * History of atrial arrhythmia (paroxysmal, persistent or permanent) * Electrocardiographic of ventricular pre-excitation or bundle-branch block (QRS \>120ms) * Ischemic heart disease * Dilated or hypertrophic cardiomyopathy * A history of heart failure, severe valvular heart disease, left ventricular dysfunction (ejection fraction \<50 percent) * A long QT interval or Brugada syndrome * The bradycardia-tachycardia syndrome (resting heart rate, ≤50 beats per minute, or repetitive sinoatrial blocks during waking hours) * Documentation of previous episodes of second or third-degree atrioventricular block * High heart rate at baseline \> 100 bmp * Renal insufficiency (Glomerular filtration rate estimated by the Cockroft and Gault formula \<30ml/min/m2), * Previous hypokalemia (potassium level \<3 mmol per liter) * Suspected or known pregnancy (woman of childbearing potential must undergo a pregnancy test) * A known hypersensibility to flecainide or its excipients * Contemporaneous enrollment in an interventional clinical trial * Intended use of a prohibited medication

Primary outcome measure(s)

percentage of patients with at least one episode of atrial arrythmia — within 3 months after PFO closure
percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episodes (≥30s) recorded on long-term monitoring with an insertable cardiac monitor (ICM) during the 3 months after PFO closure Atrial arrhythmia is defined as any episode of AF, atrial flutter or atrial tachycardia that lasts 30 seconds or more, in accordance with the 2012 consensus statement from the Heart Rhythm Society and others

Trial sites (1)

Facility	City	Region	Status
Hopital Pitié Salpetrière	Paris	IDF

More Assistance Publique - Hôpitaux de Paris trials in France

Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases Recruiting

VExUS in Ards Patients and Association with AKI Recruiting

Periodontitis and Inflammation: Study on Biological Samples Recruiting

Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation Starting soon

Creation of a Biological Collection for Medical Research Purposes for Patients at the Reference Center for Rare Diseases of the Blood Vessels of the Brain and Eye at Lariboisière Hospital Active, not recruiting

Other trials for the same condition

Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale Active, not recruiting

Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion Active, not recruiting

Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation Active, not recruiting

BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Active, not recruiting

VOLta Medical AI-software in REal-World During AF Ablation Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05213104 on ClinicalTrials.gov ↗ ← All trials in France