{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T23:38:18Z","timestamp":1793230698383,"version":"4.5.0"},"reference-count":19,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","license":[{"start":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T00:00:00Z","timestamp":1714521600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Arrhythmia and Electrophysiology"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>We previously presented the safety and early efficacy of the inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed-field Ablation [PFA] System With Irreversible Electroporation [IRE]). With the study\u2019s conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      The patient cohort included 186 patients: aged 59\u00b110 years, female 30%, and CHA\n                      <jats:sub>2<\/jats:sub>\n                      DS\n                      <jats:sub>2<\/jats:sub>\n                      -VASc 1.3\u00b11.2. The previously reported primary adverse event rate was 0%. One serious procedure-related adverse event, urinary retention, was reported. The PEE was achieved in 75.6% (95% CI, 69.5%\u201381.8%). The clinical success of freedom from symptomatic recurrence was 81.7% (95% CI, 76.1%\u201387.2%). Simulating a monitoring method used in standard real-world practice (without protocol-driven remote rhythm monitoring), this translates to a freedom from all and symptomatic recurrence of 85.8% (95% CI, 80.8%\u201390.9%) or 94.0% (95% CI, 90.6%\u201397.5%), respectively. Multivariate analyses revealed that left ventricular ejection fraction \u226560% (adjusted odds ratio, 0.30) and patients receiving \u226548 PFA applications (adjusted odds ratio, 0.28) were independent predictors of PEE success. Moreover, PEE success was 79.2% in patients who received \u226512 PFA applications per vein compared with 57.1% in patients receiving fewer PFA applications.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (\u226548 total or \u226512 per vein) resulted in an improved 1-year success rate of \u224880%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>REGISTRATION:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier: NCT04524364\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circep.123.012667","type":"journal-article","created":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T05:00:27Z","timestamp":1713934827000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":49,"title":["Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE"],"prefix":"10.1161","volume":"17","clinical-trial-number":[{"clinical-trial-number":"nct04524364","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1424-114X","authenticated-orcid":true,"given":"Tom","family":"De Potter","sequence":"first","affiliation":[{"name":"OLV Hospital, Dienst Cardiologie, Aalst, Belgium (T.D.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9347-8884","authenticated-orcid":true,"given":"Massimo","family":"Grimaldi","sequence":"additional","affiliation":[{"name":"Ospedale Generale Regionale \u201cF. Miulli\u201d UOC Cardiologia, Bari, Italy (M.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8451-0013","authenticated-orcid":true,"given":"Mattias","family":"Duytschaever","sequence":"additional","affiliation":[{"name":"AZ Sint Jan, Brugge, Belgium (M.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6864-3999","authenticated-orcid":true,"given":"Ante","family":"Anic","sequence":"additional","affiliation":[{"name":"University Hospital Center Split, Split, Croatia (A.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4928-4836","authenticated-orcid":true,"given":"Johan","family":"Vijgen","sequence":"additional","affiliation":[{"name":"Jessa Hospitals, Hasselt, Belgium (J.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4334-8165","authenticated-orcid":true,"given":"Petr","family":"Neuzil","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugo","family":"Van Herendael","sequence":"additional","affiliation":[{"name":"Ziekenhuis Oost, Genk, Belgium (H.V.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1020-9727","authenticated-orcid":true,"given":"Atul","family":"Verma","sequence":"additional","affiliation":[{"name":"McGill University Health Center, Montr\u00e9al, Canada (A.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8332-8551","authenticated-orcid":true,"given":"Allan","family":"Skanes","sequence":"additional","affiliation":[{"name":"University of Western Ontario, London, Canada (A.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Scherr","sequence":"additional","affiliation":[{"name":"Medical University Graz, Graz, Austria (D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8965-8495","authenticated-orcid":true,"given":"Helmut","family":"P\u00fcrerfellner","sequence":"additional","affiliation":[{"name":"Ordensklinikum Linz GmbH, Linz, Austria (H.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3272-4380","authenticated-orcid":true,"given":"Gediminas","family":"Rackauskas","sequence":"additional","affiliation":[{"name":"Centre for Cardiology &amp; Angiology, Department of Cardiovascular Diseases, Vilnius University, Lithuania (G.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4700-7811","authenticated-orcid":true,"given":"Pierre","family":"Jais","sequence":"additional","affiliation":[{"name":"IHU LIRYC ANR-10-IAHU-04, Centre Hospitalier Universitaire Bordeaux, Bordeaux University, Bordeaux, France (P.J.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5638-4993","authenticated-orcid":true,"given":"Vivek Y.","family":"Reddy","sequence":"additional","affiliation":[{"name":"Helmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, New York, NY; Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (V.Y.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the inspIRE Trial Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2018.04.005"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.121.010086"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.120.009229"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.120.008718"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2021.02.014"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.04.021"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2023.04.002"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.123.064959"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.123.063988"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.122.011780"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euaa157"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2022.06.007"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2307291"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2022.10.019"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euad185"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.122.011110"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hroo.2023.09.005"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.121.010375"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euad222"}],"container-title":["Circulation: Arrhythmia and Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCEP.123.012667","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T17:07:49Z","timestamp":1748538469000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCEP.123.012667"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5]]},"references-count":19,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["10.1161\/CIRCEP.123.012667"],"URL":"https:\/\/doi.org\/10.1161\/circep.123.012667","relation":{},"ISSN":["1941-3149","1941-3084"],"issn-type":[{"value":"1941-3149","type":"print"},{"value":"1941-3084","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5]]},"assertion":[{"value":"2023-12-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-12","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}