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Multicenter Study
. 2025 Oct;22(10):2551-2561.
doi: 10.1016/j.hrthm.2025.04.031. Epub 2025 Apr 26.

One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation

Vivek Y Reddy  1 , Petr Peichl  2 , Josef Kautzner  2 , Elad Anter  3 , Andreas Metzner  4 , Jacob Koruth  5 , Pierre Jais  6 , Gediminas Rackauskas  7 , Jan Petru  8 , Moritoshi Funasako  8 , Germanas Marinskis  7 , Mohit Turagam  5 , Audrius Aidietis  7 , Jada M Selma  9 , Vojtech Nejedlo  9 , Fred Kueffer  9 , Khaldoun G Tarakji  9 , Andrea Natale  10 , Petr Neuzil  8
Affiliations
Free article
Multicenter Study

One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation

Vivek Y Reddy et al. Heart Rhythm. 2025 Oct.
Free article

Abstract

Background: Most single-shot pulsed-field ablation (PFA) catheters require extensive repositioning for pulmonary vein isolation (PVI), posing a challenge for obtaining contiguous, durable lesions.

Objective: To determine 1-year outcomes of a single-shot, all-in-one mapping and ablation PFA catheter for treating paroxysmal atrial fibrillation (PAF).

Methods: After PVI with the large-lattice catheter with expandable tip (Sphere-360), follow-up included Holter monitoring at 180 and 365 days and scheduled/symptomatic trans-telephonic monitoring (TTM) or modeled insertable loop recorder (ILR) data. Efficacy outcomes were acute PVI and 12-month freedom from atrial arrhythmias (AA), after 90-day blanking. Optional invasive remapping at 75 days facilitated waveform refinement from PULSE1, PULSE2, to the optimized PULSE3.

Results: At 3 centers, 100 PAF patients underwent PFA with PULSE1 (n = 30), PULSE2 (n = 20), or PULSE3 (n = 50). Procedure, left atrial dwell, and fluoroscopy times were 57.9 ± 20.6, 22.2 ± 11.8 and 6.8 ± 5.7 minutes, respectively. All 395 targeted PVs were acutely isolated, with a transpired PVI time of 11.5 ± 6.0 minutes, using 4.0 ± 1.3 lesions/PV. There were no primary safety events (serious device-related events within 7 days post-PFA). PVI durability with PULSE3 (n = 40) was 98% (per-vein) and 93% (per-patient). One-year freedom from AA recurrence was 82.0% (95% CI:73.0%-88.3%) overall, and 88.0% (95%CI, 75.2%-94.4%) for PULSE3 patients. Of the ILR sub-cohort (n = 15 PULSE3 patients), 3 patients (20%) had recurrences, with an AA burden reduction from 26% (baseline) to 1.6% (post-ablation).

Conclusion: The large lattice PFA catheter was efficient, safe, and effective in treating PAF. The observed high PVI durability translated to clinical effectiveness, even in continuously monitored patients.

Keywords: Atrial fibrillation; Burden; Catheter ablation; Mapping; Pulsed-field ablation.

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Conflict of interest statement

Disclosures V.Y.R. is a consultant to and had received equity from Affera-Medtronic (now divested), and receives grant support from and serves as a consultant to Medtronic; and unrelated to this manuscript, he serves as a consultant for and has equity in Ablacon-Cortex, Affera-Medtronic, Anumana, APN Medical, Append Medical, Aquaheart, Atacor, Autonomix, Axon Therapies, BioSig, CardiaCare, Cardiofocus, CardioNXT / AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EP Frontiers, Field Medical, Focused Therapeutics, Heartbeam, HRT, Intershunt, Javelin, Kardium, Laminar Medical, Medlumics, Nuvera-Biosense-JNJ MedTech, Orchestra Biomed, Pulse Biosciences, Restore Medical, Sirona Medical, Volta Medical; and unrelated to this work, he has served as a consultant for Abbott, Adagio Medical, AtriAN, Biosense-JNJ MedTech, Biotronik, Boston Scientific, Cairdac, Cardionomic, Conformal Medical, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Novartis, Novo Nordisk, Philips; and unrelated to this work, he has equity in Atraverse, DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Soundcath, Surecor, and Vizaramed. E.A. is a consultant to and has received equity from Affera-Medtronic. Unrelated to this manuscript, he serves in consulting and advisory capacities for Biosense Webster, Boston Scientific, and Abbott Medical. He receives research grants from Biosense Webster and Medtronic. P.P. has received speaker honoraria from Biosense Webster, Boston Scientific, Medtronic, Biotronik, and St. Jude Medical (Abbott). G.R. reports receiving speaker honoraria from Medtronic. J.P. reports receiving speaker honoraria from Medtronic. J.S.K. has received grant support and equity from Affera-Medtronic; and unrelated to this manuscript, J.S.K. has received grant support and equity from Pulse Biosciences and Field Medical and has served as a consultant to and received grant support from CardioFocus, and served as a consultant to Abbott, Boston Scientific, Biosense Webster, Medtronic, and Abiomed. M.T. reports serving as a consultant to Boston Scientific, Biosense Webster, Medtronic, and Sanofi. J.K. reports personal fees from Biosense Webster, Boston Scientific, GE Healthcare, Medtronic, and St. Jude Medical (Abbott) for participation in scientific advisory boards, and has received speaker honoraria from Biosense Webster, Biotronik, Boston Scientific, Medtronic, and St. Jude Medical (Abbott). A.N. has served as a consultant to Abbott, Biosense Webster, Biotronik, Boston Scientific, iRhythm, Hemonetics, Field Medical, and Pulse Bioscience. P.N. reports receiving a scientific grant from Affera-Medtronic. P.J. has received partial funding from IHU LIRYC ANR-10-IAHU-04, equity from Farapulse, and consulting fees and grants from Boston Scientific. A.M. received lecture honoraria and travel fees from Medtronic, Boston Scientific, Biosense Webster, Lifetech, BMS and Bayer; he also served as a consultant for Medtronic, Boston Scientific and Biosense Webster. J.S. V.N., F.K., and K.G.T. are employees of Medtronic, Inc. The remaining authors (M.F., G.M., A.A.) report no relevant disclosures.

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