Valvular & structural heart disease
Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study
Study context
- Population
- Patients immediately after patent foramen ovale (PFO) closureplanned
- Participants
- 186 participants
- Planned comparison
- Flecainide for 6 months or 3 months vs no additional treatment after PFO closure
- Primary endpoint
- Percentage of patients with ≥1 symptomatic or asymptomatic atrial arrhythmia episode (≥30 s) on insertable cardiac monitor
- Follow-up
- Within 3 months after PFO closure
Methodological detailsrationale and design, prospective, national, multicentre, open-label, superiority, blinded endpoint evaluation (PROBE design), 1:1:1 randomisation
- Rationale and design
- Prospective
- National
- Multicentre
- Open-label
- Superiority
- Blinded endpoint evaluation (PROBE design)
- 1:1:1 randomisation
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study. Eur Heart J Cardiovasc Pharmacother. Published 12 January 2024. doi:10.
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