Safety and Effectiveness of the TactiFlex Duo System: 6-Month Results of the FOCALFLEX Study

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.