Active not recruitingPHASE3INTERVENTIONAL

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

This study, called AFLOAT, is investigating if a medication called flecainide can prevent an irregular heartbeat, known as atrial arrhythmia, in people who have had a procedure to close a small hole in their heart called a Patent Foramen Ovale (PFO). Strokes that don't have a clear cause are often linked to PFO, and closing this hole can significantly reduce the risk of another stroke. However, there's a chance of developing an irregular heartbeat afterwards. Researchers want to see if taking flecainide for either 3 or 6 months after the PFO closure can help stop these heart rhythm problems. This is the first study of its kind, and it hopes to find a new way to keep patients' hearts healthy after this important procedure.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

186

Start

23 Mar 2022

Estimated completion

01 Jul 2026

Patent Foramen Ovale Atrial Arrhythmia Cryptogenic Stroke

What is this study about?

When someone has a stroke, doctors often try to find out the cause. Sometimes, no clear cause is found, and these are called 'cryptogenic strokes'. It's been noticed that many people who have these types of strokes also have a small, naturally occurring hole in their heart called a Patent Foramen Ovale, or PFO for short. While many people have a PFO and never have problems, in some cases, it's thought that this hole allows tiny blood clots to pass from one side of the heart to the other, potentially leading to a stroke.

For people who have had a cryptogenic stroke and have a PFO, there's a procedure to close this hole. Studies have shown that closing the PFO can reduce the risk of having another stroke by at least half. However, after the PFO is closed, some people might develop an irregular heartbeat, called an atrial arrhythmia. This can sometimes be hard to spot and might not always cause obvious symptoms at first.

This study, called AFLOAT, aims to find out if a medicine called flecainide can help prevent these irregular heartbeats after the PFO closure. Flecainide is already known to be effective in treating and preventing atrial arrhythmias. The researchers believe that taking flecainide after the procedure could help keep the heart rhythm steady and reduce the overall risk for patients. This is an important step in improving care for people who have had a PFO closure.

Key takeaways

Studies suggest PFO closure reduces stroke risk, but can lead to irregular heartbeats.
AFLOAT investigates if flecainide can prevent these irregular heartbeats after PFO closure.
Participation involves taking flecainide for 3 or 6 months, or receiving standard care, plus heart monitoring.
A tiny heart monitor will be implanted to track your heart's rhythm.
This study aims to discover new ways to improve patient health after PFO closure.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been recommended by a team of specialists to have a procedure to close a PFO. This recommendation could be because you've had a stroke with no clear cause, or for other reasons like certain breathing difficulties or decompression illness.

There are also some conditions that would mean you can't join the study. For example, if you've had an irregular heartbeat before (atrial arrhythmia), or if you have certain heart problems like a specific type of heart block, very fast or slow heart rate, or serious heart disease. Also, if you have reduced kidney function, very low potassium, are pregnant or planning to become so, or are taking part in another clinical trial, you wouldn't be able to participate.

The final decision on whether you can join will be made after your PFO closure procedure. Only those with a successful closure and no major complications will be invited to have a small device implanted to monitor their heart rhythm and then be randomly assigned to one of the study groups.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 18 or older?
Has a team of doctors recommended you have a PFO closure procedure?
Have you never had an irregular heartbeat (atrial arrhythmia) before?
Do you not have certain other serious heart conditions (like severe heart failure or specific rhythm problems)?
Are you not currently pregnant or planning to be, and do you not have severe kidney problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have your PFO closure procedure. During this procedure, a small heart monitor (like a tiny recorder) will be placed inside you to keep an eye on your heart rhythm. Immediately after, you'll be put into one of three groups by chance: one group will take a specific dose of flecainide for 6 months, another group will take the same dose for 3 months, and the third group will receive standard care without flecainide. Everyone will also receive their usual ongoing medical care.

You'll have follow-up check-ups while you're in the hospital, and then again 3 months and 6 months after you go home. Doctors will also check on you remotely using information from your heart monitor. After 6 months, if you still have the monitor, your heart rhythm will continue to be tracked, even though the main treatment part of the study will have ended. The total duration of the flecainide treatment would be either 3 or 6 months, but your heart will be monitored for longer while the device is in place.

Potential risks and benefits

Taking part in this study means you might receive a medication that could help prevent irregular heartbeats after your PFO closure, which could lead to better heart health. However, like all medicines, flecainide has potential side effects, such as dizziness, nausea, or vision changes, and it's not suitable for everyone, especially those with certain heart conditions. There's also a small risk associated with having the heart monitor implanted. You will be closely monitored throughout the study to ensure your safety. It's very important to remember that you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hopital Pitié Salpetrière
Verified postcode
Paris, France

Common questions

What is a PFO?

A PFO is a small, natural hole between the upper two chambers of your heart that most people are born with. It usually closes shortly after birth, but for some, it stays open.

Why is this study looking at Flecainide?

Flecainide is a medicine known to help with irregular heartbeats. This study wants to see if it can specifically prevent these problems after a PFO closure procedure.

Will I know if I'm getting Flecainide or not?

No, you won't know which group you're in (whether you're taking flecainide for 3 months, 6 months, or just receiving standard care). This helps ensure the study results are fair and unbiased.

How long will my heart be monitored?

A small heart monitor will be implanted during your PFO closure and will continue to track your heart rhythm for a long time, potentially for as long as the device is in place, even after the main study period ends.

What if I experience side effects from the medication?

Your medical team will closely monitor you. If you experience any side effects, report them immediately, and they will provide guidance and care.