Key result
TactiFlex PFA achieves ~80% effectiveness for paroxysmal AF at six months with few safety events.
Why the study?
A dual-energy ablation system was developed to optimize targeted energy delivery via a flexible-tip contact-force sensing catheter, but long-term safety and effectiveness data for paroxysmal atrial fibrillation were lacking.
Does ablation with the TactiFlex dual-mode RF/PFA system safely and effectively prevent arrhythmia recurrence in patients with paroxysmal atrial fibrillation?
Observational (n=144)
Yes
Does ablation with the TactiFlex dual-mode RF/PFA system safely and effectively prevent arrhythmia recurrence in patients with paroxysmal atrial fibrillation?
The TactiFlex dual-mode RF/PFA system demonstrated a 79.6% primary effectiveness rate and a 1.4% primary safety event rate at 6 months for the treatment of paroxysmal atrial fibrillation.
Aims A dual-energy ablation system was developed to optimize targeted energy delivery via a flexible-tip, contact-force sensing catheter with electroanatomic mapping integration. This is the first report of long-term safety and effectiveness results of this system for ablation of paroxysmal atrial fibrillation (PAF). Methods and results The FOCALFLEX study is a prospective, multi-center study. Patients with PAF were enrolled between August 2024 and January 2025, with 144 patients (62.0±10.0 years, 62.6% male) undergoing ablation with the TactiFlex PFA System at 21 sites worldwide. Primary safety and effectiveness endpoints were the rate of pre-defined serious adverse events within 7-days and the 6-month freedom from documented AF/AFL/AT episodes >30s after a 90-day blanking period. Pulmonary vein isolation (PVI) was performed in each case with pulsed-field (PF) required for posterior left atrium (LA) ablation and radiofrequency (RF) for cavotricuspid isthmus (CTI) or near coronary arteries. Non-PV targets and modality were at physician’s discretion. Acute effectiveness was confirmed via entrance block and post-ablation LA voltage map after a 20-minute waiting period and was achieved in 99.6% (566/568) of treated PVs with 95.5±37.1 PFA applications/patient. Procedure, fluoroscopy, LA dwell, and PV ablation times were 112.2±29.5, 7.6±5.7, 81.1±19.7, and 47.4±16.4min, respectively. There were 2 (1.4%) primary safety events. At 6 months, 81.0% of subjects were free from documented arrhythmia recurrence and the protocol-defined primary effectiveness rate was 79.6%. There was 1 repeat ablation (0.7%) after the blanking period through 6 months. 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.
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Manninger et al. (2026) conducted an observational in paroxysmal atrial fibrillation (PAF) (n=144). TactiFlex PFA System was evaluated on Rate of pre-defined serious adverse events within 7-days and 6-month freedom from documented AF/AFL/AT episodes >30s after a 90-day blanking period. Ablation of paroxysmal atrial fibrillation using the TactiFlex PFA System demonstrated a 1.4% primary safety event rate and a 79.6% primary effectiveness rate at 6 months.
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