NCT05213104Active, not recruitingPhase 3
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 186 (actual)
- First submitted
- 20 Dec 2021
- Start date
- 23 Mar 2022
- Primary completion date
- 28 Feb 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT05213104
- EudraCT number
- 2021-002608-10
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 186
- From 23 Mar 2022 to the primary completion date, 28 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documentation of previous episodes of second or third-degree atrioventricular block
- Intended use of a prohibited medication
Other illness
- History of atrial arrhythmia (paroxysmal, persistent or permanent)
- Ischemic heart disease
- The bradycardia-tachycardia syndrome (resting heart rate, ≤50 beats per minute, or repetitive sinoatrial blocks during waking hours)
- High heart rate at baseline \> 100 bmp
- Renal insufficiency (Glomerular filtration rate estimated by the Cockroft and Gault formula \<30ml/min/m2),
Lab values
- A history of heart failure, severe valvular heart disease, left ventricular dysfunction (ejection fraction \<50 percent)
- A long QT interval or Brugada syndrome
- Previous hypokalemia (potassium level \<3 mmol per liter)
Other
- Electrocardiographic of ventricular pre-excitation or bundle-branch block (QRS \>120ms)
- Dilated or hypertrophic cardiomyopathy
- 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
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.