{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T09:02:29Z","timestamp":1780045349821,"version":"3.53.1"},"reference-count":15,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"12","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Arrhythmia and Electrophysiology"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:sec>\n            <jats:title>Background:<\/jats:title>\n            <jats:p>Balloon catheters facilitate pulmonary vein (PV) isolation, but current technology is limited by either a single ablative element, potentially leading to over-ablation of thin and under-ablation of thick tissue, or prolonged procedure times. Visualized by electroanatomical mapping, a novel compliant radiofrequency balloon catheter with 10 irrigated, flexible electrodes can simultaneously and independently deliver energy. Herein, we evaluated the feasibility, safety, and short-term efficacy of this radiofrequency balloon in a multicenter, single-arm, first-in-human study.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>Paroxysmal atrial fibrillation patients underwent PV isolation with the radiofrequency balloon delivered over-the-wire with a deflectable 13.5F sheath. Radiofrequency energy is delivered simultaneously from all electrodes\u2014up to 30 s posteriorly and 60 s anteriorly. Esophageal temperature was monitored in all patients; the esophagus was also mechanically deviated in 10 patients.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>At 4 sites, 39 patients were treated by 9 operators. The radiofrequency balloon isolated all targeted PVs (152\/152), 79.6% with a single application. Electrical reconnection occurred in only 7\/150 PVs (4.7%) on adenosine\/isoproterenol challenge. Mean procedure, balloon dwell, and fluoroscopy times were 101.6, 40.5, and 17.4 min, respectively. Esophagogastroduodenoscopy revealed asymptomatic esophageal erythema in 5 patients. Phrenic nerve palsy occurred in a patient in whom phrenic pacing was inadvertently omitted. At 3 months, imaging revealed no PV stenosis, and early atrial arrhythmia recurrence occurred in only 10\/39 (25.6%) patients.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>The compliant radiofrequency balloon can directionally tailor energy delivery for efficient, effective, and reasonably safe acute PV isolation.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Clinical Trial 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: ISRCTN 11764506.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circep.119.007541","type":"journal-article","created":{"date-parts":[[2019,12,12]],"date-time":"2019-12-12T10:00:19Z","timestamp":1576144819000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":40,"title":["Pulmonary Vein Isolation With a Novel Multielectrode Radiofrequency Balloon Catheter That Allows Directionally Tailored Energy Delivery"],"prefix":"10.1161","volume":"12","author":[{"given":"Vivek Y.","family":"Reddy","sequence":"first","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai, New York, NY (V.Y.R.)."},{"name":"Homolka Hospital, Prague, Czech Republic (V.Y.R., P.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Schilling","sequence":"additional","affiliation":[{"name":"Health NHS Trust St, Bartholomew\u2019s Hospital West, London, United Kingdom (R.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Grimaldi","sequence":"additional","affiliation":[{"name":"Generale Regionale F. Miulli, Bari, Italy (M.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodney","family":"Horton","sequence":"additional","affiliation":[{"name":"Texas Cardiac Arrhythmia Institute, Austin (R.H., A.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Natale","sequence":"additional","affiliation":[{"name":"Texas Cardiac Arrhythmia Institute, Austin (R.H., A.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Riva","sequence":"additional","affiliation":[{"name":"Centro Cardiologico Monzino, Milan, Italy (S.R., C.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Tondo","sequence":"additional","affiliation":[{"name":"Centro Cardiologico Monzino, Milan, Italy (S.R., C.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl-Heinz","family":"Kuck","sequence":"additional","affiliation":[{"name":"Asklepios Hospital St Georg Cardiology, Hamburg, Germany (K.-H.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petr","family":"Neuzil","sequence":"additional","affiliation":[{"name":"Homolka Hospital, Prague, Czech Republic (V.Y.R., P.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kendra","family":"McInnis","sequence":"additional","affiliation":[{"name":"Biosense Webster Inc, Irvine, CA (K.M., M.B., B.Z., A.G., A.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moe","family":"Bishara","sequence":"additional","affiliation":[{"name":"Biosense Webster Inc, Irvine, CA (K.M., M.B., B.Z., A.G., A.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baohui","family":"Zhang","sequence":"additional","affiliation":[{"name":"Biosense Webster Inc, Irvine, CA (K.M., M.B., B.Z., A.G., A.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Assaf","family":"Govari","sequence":"additional","affiliation":[{"name":"Biosense Webster Inc, Irvine, CA (K.M., M.B., B.Z., A.G., A.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"Abdelaal","sequence":"additional","affiliation":[{"name":"Biosense Webster Inc, Irvine, CA (K.M., M.B., B.Z., A.G., A.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moussa","family":"Mansour","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Boston (M.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10840-012-9672-7"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.07.036"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1602014"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2016.08.011"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2017.01.028"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.108.840587"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/jce.12491"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2007.11.006"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.115.003337"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2016.08.018"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euu352"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.joa.2014.08.002"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2015.07.015"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1111\/jce.12608"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2018.04.001"}],"container-title":["Circulation: Arrhythmia and Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCEP.119.007541","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T00:01:47Z","timestamp":1715558507000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCEP.119.007541"}},"subtitle":["Short-Term Outcomes From a Multicenter First-in-Human Study (RADIANCE)"],"short-title":[],"issued":{"date-parts":[[2019,12]]},"references-count":15,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["10.1161\/CIRCEP.119.007541"],"URL":"https:\/\/doi.org\/10.1161\/circep.119.007541","relation":{},"ISSN":["1941-3149","1941-3084"],"issn-type":[{"value":"1941-3149","type":"print"},{"value":"1941-3084","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12]]},"assertion":[{"value":"2019-05-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-10-06","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-12-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e007541"}}