{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:19:34Z","timestamp":1787008774903,"version":"build-2736575974"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2021,1,15]],"date-time":"2021-01-15T00:00:00Z","timestamp":1610668800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007497","name":"Biosense Webster, Inc","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100007497","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,6,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To evaluate the safety and effectiveness of a compliant multi-electrode radiofrequency balloon catheter (RFB) used with a multi-electrode diagnostic catheter for pulmonary vein isolation (PVI).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>This prospective, multicentre, single-arm study was conducted at six European sites and enrolled patients with symptomatic paroxysmal atrial fibrillation. The primary effectiveness endpoint was entrance block in treated pulmonary veins (PVs) after adenosine\/isoproterenol challenge. The primary safety endpoint was the occurrence of primary adverse events (PAEs) within 7\u2009days. Cerebral magnetic resonance imaging and neurological assessments were performed pre- and post-ablation in a subset of patients. Atrial arrhythmia recurrence was assessed over 12\u2009months via transtelephonic and Holter monitoring. Quality of life was assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. Of 85 patients undergoing ablation per study protocol, PV entrance block was achieved in all (one PV required touch-up with a focal catheter). Acute reconnection of \u22651 PVs after adenosine\/isoproterenol challenge was observed in 9.3% (30\/324) of PVs ablated. Post-ablation, silent cerebral lesions were detected in 9.7% (3\/31) of patients assessed, all of which was resolved at 1-month follow-up. One patient experienced a PAE (retroperitoneal bleed). Freedom from documented symptomatic and all arrhythmia was 72.2% and 65.8% at 12\u2009months. Four patients (4.7%) underwent repeat ablation. Significant improvements in all AFEQT subscale scores were seen at 6 and 12\u2009months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>PVI with the novel RFB demonstrated favourable safety and effectiveness, with low repeat ablation rate and clinically meaningful improvement in quality of life.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>ClinicalTrials.gov Registration Number<\/jats:title>\n                    <jats:p>NCT03437733.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/europace\/euaa382","type":"journal-article","created":{"date-parts":[[2020,12,9]],"date-time":"2020-12-09T22:30:33Z","timestamp":1607553033000},"page":"851-860","source":"Crossref","is-referenced-by-count":33,"title":["Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE"],"prefix":"10.1093","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0621-8241","authenticated-orcid":false,"given":"Richard","family":"Schilling","sequence":"first","affiliation":[{"name":"Department of Cardiology, St. Bartholomew\u2019s Hospital, W Smithfield, London EC1A 7BE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gurpreet Singh","family":"Dhillon","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Bartholomew\u2019s Hospital, W Smithfield, London EC1A 7BE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Tondo","sequence":"additional","affiliation":[{"name":"Monzino Cardiology Center, University of Milan, Via Carlo Parea, 4, 20138 Milano MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Riva","sequence":"additional","affiliation":[{"name":"Monzino Cardiology Center, University of Milan, Via Carlo Parea, 4, 20138 Milano MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9347-8884","authenticated-orcid":false,"given":"Massimo","family":"Grimaldi","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Ospedale Generale Regionale \u201cF. Miulli\u201d, Strada Prov. 127 Acquaviva\u2014Santeramo Km. 4, 70021 Acquaviva delle Fonti BA, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Quadrini","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Ospedale Generale Regionale \u201cF. Miulli\u201d, Strada Prov. 127 Acquaviva\u2014Santeramo Km. 4, 70021 Acquaviva delle Fonti BA, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petr","family":"Neuzil","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Na Homolce Hospital, Roentgenova 37, 150 00 Praha 5, Czechia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gian-Battista","family":"Chierchia","sequence":"additional","affiliation":[{"name":"Heart Rhythm Management Center, Universitair Ziekenhuis Brussels, Avenue du Laerbeek 101, 1090 Jette, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"de Asmundis","sequence":"additional","affiliation":[{"name":"Heart Rhythm Management Center, Universitair Ziekenhuis Brussels, Avenue du Laerbeek 101, 1090 Jette, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"Abdelaal","sequence":"additional","affiliation":[{"name":"Biosense Webster, Inc, 29b Technology Dr, Irvine, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liesbeth","family":"Vanderlinden","sequence":"additional","affiliation":[{"name":"Biosense Webster, Inc, 29b Technology Dr, Irvine, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiffany","family":"Tan","sequence":"additional","affiliation":[{"name":"Biosense Webster, Inc, 29b Technology Dr, Irvine, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wern Yew","family":"Ding","sequence":"additional","affiliation":[{"name":"Liverpool Heart and Chest Hospital, Thomas Dr, Liverpool L14 3PE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3490-090X","authenticated-orcid":false,"given":"Dhiraj","family":"Gupta","sequence":"additional","affiliation":[{"name":"Liverpool Heart and Chest Hospital, Thomas Dr, Liverpool L14 3PE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivek Y","family":"Reddy","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Na Homolce Hospital, Roentgenova 37, 150 00 Praha 5, Czechia"},{"name":"Department of Electrophysiology, Division of Cardiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. 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ablation of paroxysmal atrial fibrillation: results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) study","volume":"132","author":"Reddy","year":"2015","journal-title":"Circulation"},{"key":"2021060815591072000_euaa382-B9","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1016\/j.hrthm.2019.11.004","article-title":"Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: the CLOSE to CURE study","volume":"17","author":"Duytschaever","year":"2020","journal-title":"Heart Rhythm"},{"key":"2021060815591072000_euaa382-B10","doi-asserted-by":"crossref","first-page":"1779","DOI":"10.1161\/CIRCULATIONAHA.119.042622","article-title":"Cryoballoon or radiofrequency ablation for atrial fibrillation assessed by continuous monitoring: a randomized clinical 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