Valvular & structural heart diseaseRandomised controlled trial
Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial
- Randomised controlled trial
- prospective
- multicentre
- open-label
- superiority
- blinded end point evaluation (PROBE)
- 1:1:1 randomisation
Authors' conclusion
Flecainide did not prevent AA after PFO closure.
Study context
- Population
- Patients after patent foramen ovale (PFO) closure
- Participants
- 186 patients
- Comparison
- Flecainide for 3 or 6 months vs standard of care after PFO closure
- Flecainide 3 monthsn = 63
- Flecainide 6 monthsn = 60
- Standard of caren = 63reference
- Primary endpoint
- ≥1 episode of atrial arrhythmia (≥30 seconds) on insertable cardiac monitor
- Follow-up
- Within 3 months after PFO closure
Primary result
Atrial arrhythmia (≥30 seconds)
Risk difference
1.4%
95% CI −12.9% to 13.8%
NS
Events by treatment group
Flecainide ≥3 months vs Standard of care
risk difference 1.4% (95% CI −12.9% to 13.8%); NS
As reported in the abstract
Secondary outcomes
| Outcome | Flecainide 3 months | Flecainide 6 months | Standard of care | risk difference (95% CI) | |
|---|---|---|---|---|---|
| Atrial arrhythmia (≥30 seconds) · 3- to 6-month period after PFO closure — Flecainide 6 months vs Standard of care | 6.3% | 5.0% | 7.9% | −2.9% (−12.7% to 6.9%) | |
| Atrial arrhythmia (≥30 seconds) · 3- to 6-month period after PFO closure — Flecainide 3 months vs Standard of care | −1.6% (−11.8% to 8.6%) | ||||
| −20−10010Difference (linear scale) |
Atrial arrhythmia (≥30 seconds), all patients · 6-month follow-up
- Atrial arrhythmia (AA) in all patients
- 53 (28.5%)
- AA events in first month after PFO closure
- 86.8%
Original publication
Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial. Circulation. Published 2 September 2024. doi:10.1161/circulationaha.124.071186
Summarised from the published abstract; every number is checked against it