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Study on Flecainide to Reduce Risk of Atrial Arrhythmia After Patent Foramen Ovale Closure in Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Flecainide on patients who have undergone a procedure known as Patent Foramen Ovale (PFO) closure. A PFO is a small opening in the heart that didn't close the way it should after birth. The study is particularly interested in patients who might experience Atrial Arrhythmia or Tachycardia after this procedure. Atrial Arrhythmia refers to irregular heartbeats, while Tachycardia is a condition where the heart beats faster than normal.

The purpose of the study is to determine if Flecainide can help prevent these irregular heartbeats during the first three months after the PFO closure. Participants in the study will be monitored for any episodes of irregular heartbeats, both those that cause symptoms and those that do not. This monitoring will be done using a small device called an Insertable Cardiac Monitor (ICM), which keeps track of the heart's activity over a long period.

The study will last for several months, with participants being observed for any heart-related issues, such as palpitations, strokes, or the need for unexpected medical visits. The researchers will also look at the overall health of the participants and any side effects related to Flecainide. The goal is to gather information on how effective and safe Flecainide is in reducing the risk of heart rhythm problems after PFO closure.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be 18 years or older, candidates for a procedure called patent foramen ovale (PFO) closure, and affiliated with Social Security. A signed consent form is required.

    The indication for PFO closure must be confirmed by a multidisciplinary team.

  2. Step 2

    PFO closure procedure

    The PFO closure procedure is performed. This is a medical procedure aimed at closing a small hole in the heart.

    Successful closure without major complications is necessary for further participation in the study.

  3. Step 3

    ICM implantation and randomization

    An insertable cardiac monitor (ICM) is implanted. This device helps in long-term monitoring of heart activity.

    Randomization occurs, which means participants are assigned to different groups for the study.

  4. Step 4

    Medication administration

    Participants receive the medication flecainide orally. The purpose is to assess its effectiveness in preventing atrial arrhythmia, a type of irregular heartbeat, during the 3 months following PFO closure.

    The dosage and frequency of flecainide are determined by the study protocol.

  5. Step 5

    Monitoring period

    Heart activity is monitored for 3 months using the ICM to detect any episodes of atrial arrhythmia, which includes atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or more.

    Monitoring continues for an additional 3 months to assess the occurrence of arrhythmia and other cardiovascular events.

  6. Step 6

    Evaluation of outcomes

    The primary outcome is the percentage of participants with at least one episode of atrial arrhythmia during the first 3 months.

    Secondary outcomes include the occurrence of arrhythmia episodes, palpitations, strokes, and other cardiovascular events over 6 months, as well as any adverse effects related to flecainide.

Who can join the trial?

5 criteria

  • Patients must be **18 years of age or older**.
  • Patients should be **candidates for a procedure called PFO closure**. This is a medical procedure to close a small hole in the heart. The reason for this procedure can vary, such as preventing a stroke or other conditions. The need for this procedure must be confirmed by a team of medical experts.
  • Patients must be **affiliated with Social Security**. This means they should be part of a system that provides financial support for healthcare.
  • Patients need to have **provided a signed written consent form**. This means they have agreed to participate in the study after understanding what it involves.
  • The study will only include patients who have had a **successful PFO closure without any major complications**. This means the procedure to close the hole in the heart was completed successfully and without serious problems.

Who cannot join the trial?

4 criteria

  • Patients with a history of **atrial arrhythmia** (irregular heartbeat) or **tachycardia** (fast heartbeat) cannot participate.
  • Patients who have undergone **Patent Foramen Ovale (PFO) closure** (a procedure to close a small hole in the heart) are excluded.
  • Individuals outside the specified age range for the study are not eligible.
  • Participants who are part of a vulnerable population are not allowed in the study.
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Investigated drugs

Flecainide is a medication used in this clinical trial to see if it can help prevent atrial arrhythmia, which is a type of irregular heartbeat. The trial is focused on patients who have undergone a procedure to close a patent foramen ovale (PFO), a small hole in the heart. The goal is to determine if taking flecainide for three months after the procedure can reduce the risk of developing atrial arrhythmia or tachycardia, which is a fast heart rate.

What is already known about the treatment

Flecainide – Flecainide is administered orally in tablet form and is currently being studied in clinical trials to evaluate its effectiveness in preventing atrial arrhythmia after patent foramen ovale (PFO) closure. It is well-documented in medical literature as an antiarrhythmic medication. The main therapeutic indication for flecainide is the prevention of atrial arrhythmias, such as atrial fibrillation or tachycardia. At the molecular level, flecainide works by blocking sodium channels in the heart, which helps to stabilize the cardiac rhythm. It is classified pharmacologically as a Class IC antiarrhythmic agent.

Investigated diseases

  • Patent Foramen Ovale Closure

    This is a procedure to close a small, flap-like opening between the upper chambers of the heart that did not seal naturally after birth. Normally, this opening closes on its own, but in some people, it remains open, which can lead to complications. The closure is typically done to prevent blood clots from passing through the opening and causing strokes. Over time, the heart tissue grows over the closure device, permanently sealing the opening. The procedure is minimally invasive and usually involves inserting a device through a catheter. Recovery is generally quick, with patients often resuming normal activities shortly after.

  • Atrial Arrhythmia

    This condition involves irregular heartbeats originating from the atria, the upper chambers of the heart. It can manifest as atrial fibrillation, atrial flutter, or atrial tachycardia, each with varying patterns of irregularity. These arrhythmias can cause the heart to beat too fast, too slow, or with an irregular rhythm. Symptoms may include palpitations, dizziness, or shortness of breath, though some individuals may not experience any symptoms. Over time, atrial arrhythmias can lead to more serious complications if not managed. The condition can be episodic or persistent, affecting the heart's ability to pump blood efficiently.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513324-42-00Protocol codeAPHP201110Estimated enrolment186 patientsSponsorAssistance Publique Hopitaux De Paris

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).