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Assessment of flecainide to lower the patent foramen ovale closure risk of atrial arrhythmia or tachycardia

NCT ID NCT05213104

NEW Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

186 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Ischemic Stroke patent foramen ovale

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial arrhythmia Cryptogenic stroke Patent foramen ovale

Contacts and locations

Locations

  • Hopital Pitié Salpetrière

    Paris, IDF, 75013, France

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