{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T19:52:36Z","timestamp":1789761156687,"version":"4.0.1"},"reference-count":29,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,12,16]],"date-time":"2024-12-16T00:00:00Z","timestamp":1734307200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cardiovasc electrophysiol"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The safety and efficacy of paroxysmal atrial fibrillation (PAF) ablation with the HELIOSTAR multielectrode radiofrequency (RF) balloon catheter have been demonstrated in European studies; data from elsewhere are lacking. This prospective, multicenter study conducted in the United States, Italy, and China investigated the safety and efficacy of pulmonary vein isolation (PVI) using HELIOSTAR in drug\u2010refractory symptomatic PAF.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The primary effectiveness endpoint (PEE) was 12\u2010month freedom from documented atrial fibrillation\/atrial flutter\/atrial tachycardia plus freedom from acute procedural failure, nonstudy catheter failure, repeat ablation failure, direct current cardioversion (DCCV), and Class I\/III antiarrhythmic drug (AAD) failure. The primary safety endpoint was the occurrence of early\u2010onset primary adverse events (PAEs). Cerebral magnetic resonance imaging (MRI) and cardiac computed tomography were performed in a patient subset to assess silent cerebral lesions (SCLs) and severe pulmonary vein (PV) stenosis, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Across 36 centers, 257 eligible subjects in the main phase had the study catheter inserted. Acute PVI was achieved in all subjects, with the majority (94.1%) using the balloon catheter only. In 67.7% and 92.2% of subjects, respectively, PEE and freedom from repeat ablation were met; clinical success rate was 77.7%. The PAE rate was 5.1%. One of 15 (6.7%) subjects with MRI showed a new SCL at 1 month postablation, which resolved at 3 months. Clinically meaningful improvements in Atrial Fibrillation Effect on QualiTy\u2010of\u2010life scores were seen at 3 months and were sustained to 12 months postablation, and accompanied with reduction of Class I\/III AAD use and DCCV.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>STELLAR confirmed the safety and efficacy of the HELIOSTAR catheter for PVI, with clinically meaningful improvements in quality of life in patients with drug\u2010refractory symptomatic PAF. Most PVIs were achieved without focal touch\u2010up, and &gt;\u200990% of patients were free from repeat ablation at 12 months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>ClinicalTrials.gov Identifier: NCT03683030.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jce.16524","type":"journal-article","created":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T06:39:38Z","timestamp":1734417578000},"page":"376-386","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Multielectrode Radiofrequency Balloon Catheter for Paroxysmal Atrial Fibrillation: Results From the Global, Multicenter, STELLAR Study"],"prefix":"10.1111","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6915-9835","authenticated-orcid":false,"given":"Sandeep K.","family":"Goyal","sequence":"first","affiliation":[{"name":"Division of Cardiac Electrophysiology, Piedmont Heart Institute Atlanta Georgia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0901-6135","authenticated-orcid":false,"given":"Carlo","family":"Pappone","sequence":"additional","affiliation":[{"name":"Department of Arrhythmology IRCCS Policlinico San Donato, San Donato Milanese Milan Italy"},{"name":"Department of Arrhythmology Vita\u2010Salute San Raffaele University Milan 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 General Regional Hospital F. Miulli Bari Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sung W.","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Cardiology MedStar Southern Maryland Hospital Center Clinton Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stavros","family":"Mountantonakis","sequence":"additional","affiliation":[{"name":"Department of Cardiac Electrophysiology Northwell Health\u2010Lenox Hill Hospital New York City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. Brian","family":"DeVille","sequence":"additional","affiliation":[{"name":"Division of Cardiology The Heart Hospital Baylor Plano Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Venkata S.","family":"Sagi","sequence":"additional","affiliation":[{"name":"Baptist Heart Specialists Baptist Medical Center Jacksonville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen\u2010Yang","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Cardiology Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haseeb","family":"Jafri","sequence":"additional","affiliation":[{"name":"Kettering Physician Network Cardiac Electrophysiology Kettering Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan P.","family":"Wimmer","sequence":"additional","affiliation":[{"name":"Division of Cardiology Saint Luke's Mid 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USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9262-9433","authenticated-orcid":false,"given":"Hugh","family":"Calkins","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine Johns Hopkins University School of Medicine Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moussa","family":"Mansour","sequence":"additional","affiliation":[{"name":"Cardiac Arrhythmia Center, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Roman\u2010Gonzalez","sequence":"additional","affiliation":[{"name":"South Texas Cardiovascular Consultants, Texan Medical Center San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Natale","sequence":"additional","affiliation":[{"name":"Texas Cardiac Arrhythmia Institute, St. David's Medical Center Austin Texas USA"},{"name":"Division of Cardiology, Department of Biomedicine and Prevention University of Tor Vergata Rome Italy"},{"name":"Metro Health Medical Center, Case Western Reserve University School of Medicine Cleveland Ohio USA"},{"name":"Interventional Electrophysiology, Scripps Clinic San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7886-5467","authenticated-orcid":false,"given":"Giuseppe","family":"Ciconte","sequence":"additional","affiliation":[{"name":"Department of Arrhythmology IRCCS Policlinico San Donato, San Donato Milanese Milan Italy"},{"name":"Department of Arrhythmology Vita\u2010Salute San Raffaele University Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0932-8400","authenticated-orcid":false,"given":"Arash","family":"Aryana","sequence":"additional","affiliation":[{"name":"Mercy General Hospital and Dignity Health Heart and Vascular Institute Sacramento California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"STELLAR 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C.Delaughter et al. 12M safety\/effectiveness of very high power short duration pulmonary vein isolation with a contact force\u2010sensing temperature\u2010controlled radiofrequency catheter: the prospective nonrandomized multicenter Q\u2010FFICIENCY trial. 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