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Can a common heart drug stop rhythm problems after a Stroke-Related heart repair?

NCT ID NCT05213104

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

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Updated 1 time

Summary

Researchers test whether flecainide, an antiarrhythmic drug, can prevent atrial arrhythmias in adults who have a patent foramen ovale (PFO) closed after a cryptogenic stroke. Participants receive flecainide or standard care for 3 to 6 months. An insertable cardiac monitor records heart rhythms to detect any arrhythmia episodes lasting 30 seconds or more.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
flecainide, an antiarrhythmic drug
What this could lead to
If flecainide works, doctors could routinely prescribe it after PFO closure to lower the chance of atrial arrhythmias in stroke patients.
What could go wrong
Flecainide can cause heart rhythm problems in some people, and this trial may show it does not prevent arrhythmias after PFO closure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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