{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T13:53:35Z","timestamp":1791726815582,"version":"4.3.4"},"reference-count":42,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2024,4,8]],"date-time":"2024-04-08T00:00:00Z","timestamp":1712534400000},"content-version":"vor","delay-in-days":9,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Affera, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,3,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8\u2005Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results<\/jats:title>\n                  <jats:p>After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5\u20136\u2005s per application; \u223c4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted \u223c75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 \u00b1 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 \u00b1 21.6, 10.0 \u00b1 6.0, 19.1 \u00b1 9.3, and 5.7 \u00b1 3.9\u2005min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan\u2013Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2\u201389.2%) for the total, and 100% (95% CI 80.6\u2013100%) for the PULSE3 cohort.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/europace\/euae090","type":"journal-article","created":{"date-parts":[[2024,4,8]],"date-time":"2024-04-08T06:55:49Z","timestamp":1712559349000},"source":"Crossref","is-referenced-by-count":35,"title":["First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation"],"prefix":"10.1093","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5638-4993","authenticated-orcid":false,"given":"Vivek Y","family":"Reddy","sequence":"first","affiliation":[{"name":"Department of Cardiology, Icahn School of Medicine at Mount Sinai , One Gustave Levy Place, Box 1030, New York, NY, USA"},{"name":"Department of Cardiology, Homolka Hospital , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8199-2288","authenticated-orcid":false,"given":"Elad","family":"Anter","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Shamir Medical Center , Be'er Yaakov, Tel Aviv , Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5625-0071","authenticated-orcid":false,"given":"Petr","family":"Peichl","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Institute for Clinical and Experimental Medicine-IKEM , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3272-4380","authenticated-orcid":false,"given":"Gediminas","family":"Rackauskas","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Vilnius University , Vilnius , Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Petru","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Homolka Hospital , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1620-3924","authenticated-orcid":false,"given":"Moritoshi","family":"Funasako","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Homolka Hospital , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2221-8372","authenticated-orcid":false,"given":"Jacob S","family":"Koruth","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Icahn School of Medicine at Mount Sinai , One Gustave Levy Place, Box 1030, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Germanas","family":"Marinskis","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Vilnius University , Vilnius , Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohit","family":"Turagam","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Icahn School of Medicine at Mount Sinai , One Gustave Levy Place, Box 1030, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Audrius","family":"Aidietis","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Vilnius University , Vilnius , Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1632-6182","authenticated-orcid":false,"given":"Josef","family":"Kautzner","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Institute for Clinical and Experimental Medicine-IKEM , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6601-944X","authenticated-orcid":false,"given":"Andrea","family":"Natale","sequence":"additional","affiliation":[{"name":"Texas Cardiac Arrhythmia Institute , St. David\u2019s Medical Center, Austin, TX, USA"},{"name":"Department of Biomedicine and Prevention, Division of Cardiology, University of Tor Vergata , Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4334-8165","authenticated-orcid":false,"given":"Petr","family":"Neuzil","sequence":"additional","affiliation":[{"name":"Department of Cardiology, 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