Arrhythmias & electrophysiologyCohort study
Safety and effectiveness of the TactiFlex duo system: 6-month results of the FOCALFLEX study
- Prospective single-arm study
- multicentre
- 21 sites worldwide
- Enrolment August 2024 – January 2025
Authors' conclusion
The FOCALFLEX study results demonstrate safety and effectiveness of a novel dual-mode RF/PFA system through 6 months of follow-up to treat symptomatic, recurrent PAF.
Study context
- Population
- Patients with paroxysmal AF
- Participants
- 144 patients · 21 sites
- Outcome
- Safety: pre-defined serious adverse events within 7 days; effectiveness: freedom from documented AF/AFL/AT episodes >30 s after a 90-day blanking period
- Follow-up
- 7 days (safety); 6 months (effectiveness)
Main finding
As reported in the abstract
Primary effectiveness (freedom from documented AF/AFL/AT >30 s after 90-day blanking) · 6 months
Protocol-defined primary effectiveness rate
79.6%
Observational data: associations, not effects.
Further findings
Freedom from documented arrhythmia recurrence · 6 months
- Free from documented arrhythmia recurrence
- 81.0%
Acute effectiveness (entrance block + post-ablation left atrium (LA) voltage map after 20-min wait)
- Treated PVs achieved
- 99.6% (566/568)
- Pulsed field ablation (PFA) applications/patient, mean ± SD
- 95.5 ± 37.1
Procedure, fluoroscopy, LA dwell and PV ablation times
- Procedure time
- 112.2 ± 29.5 min
- Fluoroscopy time
- 7.6 ± 5.7 min
- LA dwell time
- 81.1 ± 19.7 min
- PV ablation time
- 47.4 ± 16.4 min
Repeat ablation after blanking period · through 6 months
- Repeat ablation
- 1 (0.7%)
Safety
Primary safety events (pre-defined serious AEs within 7 days)
- Primary safety events
- 2 (1.4%)
Original publication
Safety and effectiveness of the TactiFlex duo system: 6-month results of the FOCALFLEX study. Europace. Published 7 May 2026. doi:10.1093/europace/euag108
Summarised from the published abstract; every number is checked against it