Safety and effectiveness of a novel dual-energy radiofrequency/pulsed field ablation catheter: 12-month results of the FlexPulse study
Abstract
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 and results: 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. 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%.
Conclusion: In this trial, ablation with TactiFlex Duo in patients with symptomatic, drug-refractory PAF was safe and effective.
Related
- Predictive Value of Left Atrial Strain Combined with Low-Voltage Substrate for Recurrence After Radiofrequency Catheter Ablation in Persistent Atrial Fibrillation
- Radiofrequency ablation with a conventional solid tip catheter in contact with an implantable cardioverter-defibrillator coil causing inadvertent ventricular fibrillation.
- Dual-Energy Pulsed Field and Radiofrequency Ablation With a Contact Force-Sensing Focal Catheter for Ventricular Arrhythmias: Initial Clinical Experience
- Massive Left Atrial Thrombosis Shortly After Radiofrequency Catheter Ablation: Implications of Reduced Flow Dynamics Detected by Four-Dimensional Flow Magnetic Resonance Imaging.
- Left Inferior Pulmonary Vein Thrombosis and Secondary Lung Infarction Following Radiofrequency Catheter Ablation: A Diagnostic Challenge.
BibTeX
@article{hussein2026safety,
title = {{Safety and effectiveness of a novel dual-energy radiofrequency/pulsed field ablation catheter: 12-month results of the FlexPulse study}},
author = {Ayman A Hussein and Gediminas Rackauskas and Sri Sundaram and Jonathan P Piccini and Franz Xaver Roithinger and Patricia Tung and Jose Osorio and B Judson Colley and Usman R Siddiqui and Dhanunjaya R Lakkireddy and Larry A Chinitz and Matthew C Hyman and Laura Zitella Verbick and Nick Dirckx and Virginia Woods and Monica Lo},
journal = {Europace},
year = {2026},
month = aug,
doi = {10.1093/europace/euag238},
url = {https://doi.org/10.1093/europace/euag238},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Safety and effectiveness of a novel dual-energy radiofrequency/pulsed field ablation catheter: 12-month results of the FlexPulse study
AU - Ayman A Hussein
AU - Gediminas Rackauskas
AU - Sri Sundaram
AU - Jonathan P Piccini
AU - Franz Xaver Roithinger
AU - Patricia Tung
AU - Jose Osorio
AU - B Judson Colley
AU - Usman R Siddiqui
AU - Dhanunjaya R Lakkireddy
AU - Larry A Chinitz
AU - Matthew C Hyman
AU - Laura Zitella Verbick
AU - Nick Dirckx
AU - Virginia Woods
AU - Monica Lo
PY - 2026
DA - 2026/08/28
JO - Europace
DO - 10.1093/europace/euag238
UR - https://doi.org/10.1093/europace/euag238
AB - 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 and results: 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. 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%. Conclusion: In this trial, ablation with TactiFlex Duo in patients with symptomatic, drug-refractory PAF was safe and effective.
SN - 1099-5129
SN - 1532-2092
ER -