{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T18:57:08Z","timestamp":1770836228798,"version":"3.50.1"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2021,12,15]],"date-time":"2021-12-15T00:00:00Z","timestamp":1639526400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,7,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>Cryoballoon (CB) based pulmonary vein isolation (PVI) is a widely used technique for treatment of atrial fibrillation (AF); however the ideal energy dosing has not yet been standardized. This was a single-centre randomized clinical trial aiming at assessing the safety, acute efficacy, and clinical outcome of an individualized vs. a fixed CB ablation protocol using the fourth-generation CB (CB4) guided by pulmonary vein (PV) potential recordings and CB temperature.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results<\/jats:title>\n                  <jats:p>Patients were randomized in a 1:1 fashion to two different dosing protocols: INDI-FREEZE group (individualized protocol): freeze-cycle duration of time to effect plus 90 s or interruption of the freeze-cycle and repositioning CB if a CB temperature of \u221230\u00b0C was not within 40 s. Control group (fixed protocol): freeze-cycle duration of 180 s. No-bonus freeze-cycle was applied in either patient group. The primary endpoint was freedom from atrial tachyarrhythmia at 12 months. Secondary end points included procedural parameters and complications. A total of 100 patients with paroxysmal AF were prospectively enrolled. No difference was seen in the primary endpoint [INDI-FREEZE group: 38\/47 (81%) vs. control group: 40\/47, (85%), P = 0.583]. The total freezing time was significantly shorter in the INDI-FREEZE group (157 \u00b1 56 s vs. 212 \u00b1 83 s, P &amp;lt; 0.001), while procedure duration (57.9 \u00b1 17.9 min vs. 63.2 \u00b1 20.2 min, P = 0.172) was similar. No differences were seen in the minimum CB and oesophageal temperatures as well as in periprocedural complications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Compared to the fixed protocol, the individualized approach provides a similar safety profile and clinical outcome, while reducing the total freezing time.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/europace\/euab305","type":"journal-article","created":{"date-parts":[[2021,12,6]],"date-time":"2021-12-06T20:14:43Z","timestamp":1638821683000},"page":"921-927","source":"Crossref","is-referenced-by-count":18,"title":["Individualized or fixed approach to pulmonary vein isolation utilizing the fourth-generation cryoballoon in patients with paroxysmal atrial fibrillation: the randomized INDI-FREEZE trial"],"prefix":"10.1093","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9014-8097","authenticated-orcid":false,"given":"Christian Hendrik","family":"Heeger","sequence":"first","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"},{"name":"German Center for Cardiovascular Research (DZHK), Partner Site Hamburg\/Kiel\/L\u00fcbeck , L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sorin Stefan","family":"Popescu","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"},{"name":"Carol Davila, University of Medicine and Pharmacy , Bucharest , Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roza","family":"Saraei","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bettina","family":"Kirstein","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sascha","family":"Hatahet","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Omar","family":"Samara","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Traub","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcel","family":"Fehe","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriele","family":"D\u2019Ambrosio","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahmad","family":"Keelani","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Schl\u00fcter","sequence":"additional","affiliation":[{"name":"LANS Cardio , Stephansplatz 5 , 20354 Hamburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charlotte","family":"Eitel","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia","family":"Vogler","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karl Heinz","family":"Kuck","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"},{"name":"LANS Cardio , Stephansplatz 5 , 20354 Hamburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roland Richard","family":"Tilz","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein , Ratzeburger Allee 160, D-23538 L\u00fcbeck , Germany"},{"name":"German Center for Cardiovascular Research (DZHK), Partner Site Hamburg\/Kiel\/L\u00fcbeck , L\u00fcbeck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,12,15]]},"reference":[{"key":"2022071421513781200_euab305-B1","doi-asserted-by":"crossref","first-page":"2235","DOI":"10.1056\/NEJMoa1602014","article-title":"Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation","volume":"374","author":"Kuck","year":"2016","journal-title":"N Engl J 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First-in-man experience and procedural efficacy of pulmonary vein isolation using the third-generation cryoballoon","volume":"105","author":"Heeger","year":"2016","journal-title":"Clin Res Cardiol"},{"key":"2022071421513781200_euab305-B6","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1016\/j.hrthm.2016.12.014","article-title":"Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial","volume":"14","author":"Chun","year":"2017","journal-title":"Heart Rhythm"},{"key":"2022071421513781200_euab305-B7","doi-asserted-by":"crossref","first-page":"1658","DOI":"10.1016\/j.hrthm.2015.03.021","article-title":"Best practice guide for cryoballoon ablation in atrial fibrillation: the compilation experience of more than 3000 procedures","volume":"12","author":"Su","year":"2015","journal-title":"Heart Rhythm"},{"key":"2022071421513781200_euab305-B8","doi-asserted-by":"crossref","first-page":"918","DOI":"10.1111\/jce.13927","article-title":"The fourth cryoballoon generation with a shorter tip to facilitate real-time pulmonary vein potential recording: feasibility and safety results","volume":"30","author":"Straube","year":"2019","journal-title":"J Cardiovasc Electrophysiol"},{"key":"2022071421513781200_euab305-B9","doi-asserted-by":"crossref","first-page":"1553","DOI":"10.1111\/jce.15009","article-title":"Experience and procedural efficacy of pulmonary vein isolation using the fourth and second generation cryoballoon: the shorter, the better?","volume":"32","author":"Heeger","year":"2021","journal-title":"J Cardiovasc Electrophysiol"},{"key":"2022071421513781200_euab305-B10","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1161\/CIRCEP.113.000228","article-title":"Increased incidence of esophageal thermal lesions using the second-generation 28-mm cryoballoon","volume":"6","author":"Metzner","year":"2013","journal-title":"Circ Arrhythm Electrophysiol"},{"key":"2022071421513781200_euab305-B11","doi-asserted-by":"crossref","first-page":"1676","DOI":"10.1093\/europace\/euw233","article-title":"First insights into cryoballoon-based pulmonary vein isolation taking the individual time-to-isolation into account","volume":"19","author":"Reissmann","year":"2017","journal-title":"Europace"},{"key":"2022071421513781200_euab305-B12","doi-asserted-by":"crossref","first-page":"1459","DOI":"10.1093\/europace\/eux219","article-title":"Is less more? 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