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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002608-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Fonds de Dotation ACTION | OTHER |
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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.
AFLOAT is a national, multicenter, randomized, controlled, open-label superiority study with a blind evaluation of all the endpoints (PROBE design).
The interventional phase is followed by an observational phase as long as the patient is implanted with the ICM during when only the data of the device will be collected.
Screening and selection occurs before the procedure of PFO closure and an inform consent form is signed.
During the procedure of PFO closure, a small ICM (CONFIRM RX, ABBOTT) providing a long-term monitoring is implanted to detect all AA episodes.
Immediately after PFO closure, patients are randomly assigned, in a 1:1:1 ratio, in 3 groups : flecainide (150 mg per day in a single sustained-release dose) for 6 months (in addition to standard of care), flecainide (150 mg per day in a single sustained-release dose) for 3 months (in addition to standard Clinical follow-up is conducted during hospitalization, at 3 months (M3) and 6 months (M6-end-of-interventionnal phase) after discharge. A contrast echocardiography is recommended between 1 and 6 months. Telemonitoring provides notifications in case of arrhythmic event.
An observational period in patients who will keep the ICM beyond the 6-month follow-up period. Atrial arrhythmia detection will be continued.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 - Flecainide 150 mg 6 months | Experimental | Flecainide 150 mg 6 months in addition to standard of care |
|
| group 2 - Flecainide 150 mg 3 months | Experimental | Flecainide 150 mg 3 months in addition to standard of care |
|
| group 3 - no Flecainide | No Intervention | to receive no additional treatment (standard of care only). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flecainide | Drug | Flecainide 150 mg 6 months in addition to standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with at least one episode of atrial arrythmia | percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episodes (≥30s) recorded on long-term monitoring with an insertable cardiac monitor (ICM) during the 3 months after PFO closure Atrial arrhythmia is defined as any episode of AF, atrial flutter or atrial tachycardia that lasts 30 seconds or more, in accordance with the 2012 consensus statement from the Heart Rhythm Society and others | within 3 months after PFO closure |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with at least one episode of atrial arrythmia(AA) | Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥30s) recorded on long-term monitoring with ICM between 3 and 6 months after PFO closure | between the 3-months and 6-months follow-up visits |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with AA≥6 min | Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥6 min) recorded on long-term monitoring with ICM device during the 3 months after PFO closure | within 3 months after PFO closure |
| percentage of stroke or TIA |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giles MONTALESCOT, MD,PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Pitié Salpetrière | Paris | IDF | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39222035 | Derived | Hauguel-Moreau M, Guedeney P, Dauphin C, Auffret V, Clerc JM, Marijon E, Elbaz M, Aldebert P, Beygui F, Abi Khalil W, Da Costa A, Macia JC, Elhadad S, Cayla G, Iriart X, Laredo M, Rolland T, Temmar Y, Gheorghiu ME, Brugier D, Silvain J, Hammoudi N, Duthoit G, Diallo A, Vicaut E, Montalescot G; ACTION Study Group. Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial. Circulation. 2024 Nov 19;150(21):1659-1668. doi: 10.1161/CIRCULATIONAHA.124.071186. Epub 2024 Sep 2. | |
| 38216511 |
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| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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| ID | Term |
|---|---|
| D005424 | Flecainide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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randomized, controlled, open-label study with a blind evaluation of all the endpoints (PROBE design)
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only outcomes assessor will be blinded to the study arm (PROBE design)
| Flecainide | Drug | Flecainide 150 mg 3 months in addition to standard of care |
|
|
Percentage of patients with at least one episode of fatal or non-fatal stroke or Transient Ischemic Attack (TIA) during the 3 and 6 months after PFO closure |
| within 6 months after PFO closure |
| Percentage of non-scheduled practitioner-consultation or hospitalization for any cardiovascular reason | Percentage of patients with at least one episode of non-scheduled practitioner-consultation or hospitalization for any cardiovascular reason during the 3 and 6 months after PFO closure | within 6 months after PFO closure |
| All-cause mortality | All-cause mortality during the 3 and 6 months after PFO closure | within 6 months after PFO closure |
| Rate of Flecainide-related adverse events | Rate of Flecainide-related adverse events | from the Day 0 (V0) to the 6 months follow-up visit (V2) |
| Percentage of patients with at least one episode of symptomatic or asymptomatic AA | Percentage of patients with at least one episode of symptomatic or asymptomatic AA episodes (≥6 min) recorded on long-term monitoring with ICM device during the whole follow-up period until battery run out or ICM removal. | from Day 0 (V0) till the ICM explantation (up to 2.5 years) |
| Derived |
| Hauguel-Moreau M, Guedeney P, Dauphin C, Auffret V, Marijon E, Aldebert P, Clerc JM, Beygui F, Elbaz M, Khalil WA, Da Costa A, Macia JC, Elhadad S, Cayla G, Brugier D, Silvain J, Hammoudi N, Duthoit G, Vicaut E, Montalescot G; ACTION Study Group. Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study. Eur Heart J Cardiovasc Pharmacother. 2024 May 4;10(3):184-189. doi: 10.1093/ehjcvp/pvad100. |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |