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Assessment of Flecainide to Lower the patent foramen Ovale closure risk of Atrial arrhythmia or Tachycardia
EU CTIS ID: 2024-513324-42-00
What this study is testing
To assess if flecainide is efficient to prevent atrial arrhythmia (AA) occurrence during the 3 months after PFO closure
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients are ≥ 18 years of age
- 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.
- Affiliated to Social Security
- Patients have provided a signed written consent form
- ICM implantation and randomization will occur only in patients with successful PFO closure without any major complications
You likely can't join if
- History of atrial arrhythmia (paroxysmal, persistent or permanent)
- 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
See the full eligibility criteria
- Patients are ≥ 18 years of age
- 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.
- Affiliated to Social Security
- Patients have provided a signed written consent form
- ICM implantation and randomization will occur only in patients with successful PFO closure without any major complications
- History of atrial arrhythmia (paroxysmal, persistent or permanent)
- 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 (see 7.4.1)
- 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.