Flecainide to prevent atrial arrhythmia after patent foramen ovale closure Rationale and design of the randomized AFLOAT study - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue European Heart Journal - Cardiovascular Pharmacotherapy Année : 2024

Flecainide to prevent atrial arrhythmia after patent foramen ovale closure Rationale and design of the randomized AFLOAT study

Claire Dauphin
  • Fonction : Auteur
Eloi Marijon
Philippe Aldebert
Farzin Beygui
Meyer Elbaz
Antoine da Costa
Simon El-Hadad
Éric Vicaut

Résumé

Introduction: Atrial arrhythmia is the most common complication of patent foramen ovale (PFO) closure. The real incidence of post-PFO closure atrial arrhytmia and whether this complication can be prevented is unknown.Methods/design: The Assessment of Flecainide to Lower the patent foramen Ovale closure risk of Atrial fibrillation or Tachycardia (AFLOAT) trial is a prospective, national, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the endpoints (PROBE design). A total of 186 patients are randomized in a 1:1:1 ratio immediately after PFO closure to receive Flecainide (150 mg per day in a single sustained-release dose) for 6 months (Group 1), Flecainide (150 mg per day in a single sustained-release dose) for 3 months (Group 2), or no additional treatment (standard of care) for 6 months (Group 3). The primary endpoint is the percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episode (≥30s) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. Whether 3 months of treatment is sufficient compared to 6 months will be analyzed as a secondary objective of the study.Conclusion: AFLOAT is the first trial to test the hypothesis that a short treatment with oral Flecainide can prevent the new-onset of atrial arrhythmia after PFO closure. Clinical trial registration: NCT05213104 (clinicaltrials.gov).
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Dates et versions

hal-04429377 , version 1 (31-01-2024)

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Citer

Marie Hauguel-Moreau, Paul Guedeney, Claire Dauphin, Vincent Auffret, Eloi Marijon, et al.. Flecainide to prevent atrial arrhythmia after patent foramen ovale closure Rationale and design of the randomized AFLOAT study. European Heart Journal - Cardiovascular Pharmacotherapy, 2024, European Heart Journal-Cardiovascular Pharmacotherapy, ⟨10.1093/ehjcvp/pvad100⟩. ⟨hal-04429377⟩
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