Flecainide to prevent atrial arrhythmia after patent foramen ovale closure Rationale and design of the randomized AFLOAT study
© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology..
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).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
European heart journal. Cardiovascular pharmacotherapy - (2024) vom: 12. Jan. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hauguel-Moreau, Marie [VerfasserIn] |
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| Links: |
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| Themen: |
Atrial Fibrillation |
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| Anmerkungen: |
Date Revised 12.01.2024 published: Print-Electronic ClinicalTrials.gov: NCT05213104 Citation Status Publisher |
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| doi: |
10.1093/ehjcvp/pvad100 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367070618 |
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| 100 | 1 | |a Hauguel-Moreau, Marie |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Flecainide to prevent atrial arrhythmia after patent foramen ovale closure Rationale and design of the randomized AFLOAT study |
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| 500 | |a Date Revised 12.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05213104 | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Atrial Fibrillation | |
| 650 | 4 | |a Flecainide | |
| 650 | 4 | |a Patent Foramen Ovale | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 700 | 1 | |a Guedeney, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Dauphin, Claire |e verfasserin |4 aut | |
| 700 | 1 | |a Auffret, Vincent |e verfasserin |4 aut | |
| 700 | 1 | |a Marijon, Eloi |e verfasserin |4 aut | |
| 700 | 1 | |a Aldebert, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Clerc, Jean-Michel |e verfasserin |4 aut | |
| 700 | 1 | |a Beygui, Farzin |e verfasserin |4 aut | |
| 700 | 1 | |a Elbaz, Meyer |e verfasserin |4 aut | |
| 700 | 1 | |a Khalil, Wissam Abi |e verfasserin |4 aut | |
| 700 | 1 | |a Da Costa, Antoine |e verfasserin |4 aut | |
| 700 | 1 | |a Macia, Jean-Christophe |e verfasserin |4 aut | |
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| 700 | 1 | |a Hammoudi, Nadjib |e verfasserin |4 aut | |
| 700 | 1 | |a Duthoit, Guillaume |e verfasserin |4 aut | |
| 700 | 1 | |a Vicaut, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Montalescot, Gilles |e verfasserin |4 aut | |
| 700 | 0 | |a ACTION Study Group |e verfasserin |4 aut | |
| 700 | 1 | |a Montalescot, Gilles |e investigator |4 oth | |
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| 700 | 1 | |a Iriart, Xavier |e investigator |4 oth | |
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