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Safety and Effectiveness of a Novel Dual-Energy Radiofrequency/Pulsed Field Ablation Catheter: 12 Month Results of the FlexPulse Study
Key result
TactiFlex Duo ablation achieves ~75% freedom from the primary composite outcome in refractory paroxysmal AF.
- n=180
Why the study?
Pulsed field ablation is increasingly used for paroxysmal AF, but the safety and effectiveness of a novel dual-energy, flexible-tip focal ablation catheter combining radiofrequency and pulsed field required evaluation.
Structured PICO
P
Population
180 subjects with symptomatic, drug-refractory paroxysmal atrial fibrillation undergoing ablation with a novel dual-energy catheter, followed for 12 months.
I
Intervention
Ablation with a novel dual-energy, flexible-tip focal ablation catheter (radiofrequency and pulsed field, TactiFlex Duo) targeting pulmonary vein isolation (PVI) and adjunctive non-PV ablation at operators' discretion.
O
Outcome
Co-primary endpoints: 1) Primary safety endpoint: occurrence of pre-defined safety events within 7-days of any ablation procedure; 2) Primary effectiveness endpoint: freedom from a composite of recurrent AF/atrial tachycardia/atrial flutter, repeat procedure, new use or escalation of class I/III AAD, and/or cardioversion through 12-months.composite
A novel dual-energy radiofrequency and pulsed field ablation catheter demonstrated a 74.6% 12-month freedom from a composite of recurrent arrhythmias and related interventions with a low 1.7% safety event rate in patients with paroxysmal AF.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“As physicians, we're looking for technologies that help us confidently deliver the best possible outcomes for our patients, not just at the time of the procedure, but for years afterward. The evidence behind this device helps increase confidence in ablation therapy and hopefully support lasting outcomes for patients with atrial fibrillation.”
Implication
Supports dual-energy catheter feasibility in paroxysmal AF; leaves open randomized confirmation of efficacy and safety.
Abstract
BACKGROUND AND AIMS: Pulsed field (PF) ablation is increasingly used to treat paroxysmal atrial fibrillation (PAF). FlexPulse (NCT06676072) was conducted to evaluate safety and effectiveness of a novel dual-energy, flexible-tip focal ablation catheter with radiofrequency and PF for treatment of symptomatic, drug-refractory PAF. METHODS: FlexPulse was a global, prospective, single arm, multicentre study. The ablation procedures targeted pulmonary vein isolation (PVI) and adjunctive ablation at operators' discretion. The primary safety endpoint was occurrence of pre-defined safety events within 7-days of any ablation procedure. The primary effectiveness endpoint was freedom from a composite of recurrent AF/atrial tachycardia/atrial flutter, repeat procedure, new use or escalation of class I/III AAD, and/or cardioversion through 12-months. RESULTS: Overall, 180 subjects underwent PAF ablation. Successful PVI was achieved in all participants. Additional non-PV ablations were performed in 37.2% (67/180) of subjects. The primary safety endpoint event rate was 1.7%. The primary effectiveness endpoint was 74.6% at 12-months, and freedom from documented AF/AFL/AT recurrence was 77.4% (92.6% without weekly transtelephonic monitoring). In 15 subjects who underwent repeat ablation after the blanking period, remapping indicated that 79.7% (47/59) of the PVs were durably isolated from the index procedures. Retrospective analysis found that workflows with PFA Index (PI) ≥30 and AutoMark distance up to 6 mm target had a 12-month freedom from AF/AFL/AT of 84.6%. CONCLUSIONS: In this trial, ablation with TactiFlex Duo in patients with symptomatic, drug-refractory PAF was safe and effective.
Discussion
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Cite This Study
Hussein et al. (2026) studied symptomatic, drug-refractory paroxysmal atrial fibrillation (PAF) (n=180). TactiFlex Duo dual-energy radiofrequency/pulsed field ablation catheter was evaluated on freedom from a composite of recurrent AF/atrial tachycardia/atrial flutter, repeat procedure, new use or escalation of class I/III AAD, and/or cardioversion through 12-months. Ablation with the TactiFlex Duo catheter in drug-refractory paroxysmal atrial fibrillation achieved 74.6% freedom from the primary effectiveness composite at 12 months, with a 1.7% safety event rate.