{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T15:08:57Z","timestamp":1787843337672,"version":"build-2784847793"},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,3,6]],"date-time":"2024-03-06T00:00:00Z","timestamp":1709683200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008497","name":"Boston Scientific Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008497","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cardiovasc electrophysiol"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28\u2009mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open\u2010label, prospective, single\u2010arm study on the safety and performance of a novel cryoballoon system for treatment of PAF.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Results<\/jats:title><jats:p>The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS\u00a0consensus statement. Follow\u2010up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean\u2009\u00b1\u2009SD or median (IQR). PVI was performed with a 28\u2009mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60\u2009s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade\/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re\u2010initiated in 26.8% of patients after the 3\u2010month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28\/31\u2009mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jce.16220","type":"journal-article","created":{"date-parts":[[2024,3,7]],"date-time":"2024-03-07T04:15:38Z","timestamp":1709784938000},"page":"832-842","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["One\u2010year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial"],"prefix":"10.1111","volume":"35","author":[{"given":"Kenneth A.","family":"Ellenbogen","sequence":"first","affiliation":[{"name":"Division of Cardiology Virginian Commonwealth University Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suneet","family":"Mittal","sequence":"additional","affiliation":[{"name":"Valley Hospital Ridgewood New Jersey 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Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Devi","family":"Nair","sequence":"additional","affiliation":[{"name":"Arrhythmia Research Group Jonesboro Arkansas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Champagne","sequence":"additional","affiliation":[{"name":"Institut Universitaire de Cardiologie et de Pneumologie de Quebec Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2131-1110","authenticated-orcid":false,"given":"Saverio","family":"Iacopino","sequence":"additional","affiliation":[{"name":"Maria Cecilia Hospital Cotignola Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"de Asmundis","sequence":"additional","affiliation":[{"name":"UZ Brussel Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanislav","family":"Weiner","sequence":"additional","affiliation":[{"name":"Christus 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