Safety and effectiveness of the TactiFlex duo system: 6-month results of the FOCALFLEX study

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).

The FOCALFLEX study is a prospective, multicentre 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 >30 s after a 90-day blanking period.

Pulmonary vein isolation (PVI) was performed in each case with pulsed field required for posterior left atrium (LA) ablation and radiofrequency (RF) for cavotricuspid isthmus 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-min waiting period and was achieved in 99.6% (566/568) of treated PVs with 95.5 ± 37.1 pulsed field ablation (PFA) applications/patients. Procedure, fluoroscopy, LA dwell, and PV ablation times were 112.2 ± 29.5, 7.6 ± 5.7, 81.1 ± 19.7, and 47.4 ± 16.4 min, respectively. There were two (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 one repeat ablation (0.7%) after the blanking period through 6 months.

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.

ClinicalTrials.gov Identifier: NCT06271967