{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T07:19:23Z","timestamp":1740122363886,"version":"3.37.3"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"8","license":[{"start":{"date-parts":[[2024,6,3]],"date-time":"2024-06-03T00:00:00Z","timestamp":1717372800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2024,6,3]],"date-time":"2024-06-03T00:00:00Z","timestamp":1717372800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Interv Card Electrophysiol"],"DOI":"10.1007\/s10840-024-01836-5","type":"journal-article","created":{"date-parts":[[2024,6,3]],"date-time":"2024-06-03T22:01:41Z","timestamp":1717452101000},"page":"1833-1842","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["In vivo safety and pulmonary vein isolation performance of a new cryoballoon for the treatment of atrial fibrillation"],"prefix":"10.1007","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3106-7318","authenticated-orcid":false,"given":"Rong","family":"Bai","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu","family":"Liao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xunzhang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Rosenthal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Justin","family":"Vessey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meital","family":"Mazor","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0639-6822","authenticated-orcid":false,"given":"Wilber","family":"Su","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,6,3]]},"reference":[{"issue":"5","key":"1836_CR1","doi-asserted-by":"publisher","first-page":"373","DOI":"10.1093\/eurheartj\/ehaa612","volume":"42","author":"G Hindricks","year":"2021","unstructured":"Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstr\u00f6m-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL, ESC Scientific Document Group. 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): the Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021;42(5):373\u2013498. https:\/\/doi.org\/10.1093\/eurheartj\/ehaa612.","journal-title":"Eur Heart J"},{"issue":"3","key":"1836_CR2","doi-asserted-by":"publisher","first-page":"609","DOI":"10.1007\/s10840-022-01200-5","volume":"65","author":"A Martin","year":"2022","unstructured":"Martin A, Fowler M, Breskovic T, Ouss A, Dekker L, Yap SC, Bhagwandien R, Albrecht EM, Cielen N, Richards E, Tran BC, Lever N, Anic A. Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long-term outcomes in a multicentre clinical study. J Interv Card Electrophysiol. 2022;65(3):609\u201316. https:\/\/doi.org\/10.1007\/s10840-022-01200-5.","journal-title":"J Interv Card Electrophysiol"},{"issue":"2","key":"1836_CR3","doi-asserted-by":"publisher","first-page":"226","DOI":"10.1093\/europace\/euab281","volume":"24","author":"LB Shi","year":"2022","unstructured":"Shi LB, Rossvoll O, Tande P, Schuster P, Solheim E, Chen J. Cryoballoon vs. radiofrequency catheter ablation: insights from NOrwegian randomized study of PERSistent Atrial Fibrillation (NO-PERSAF study). Europace. 2022;24(2):226\u201333. https:\/\/doi.org\/10.1093\/europace\/euab281.","journal-title":"Europace"},{"issue":"8","key":"1836_CR4","doi-asserted-by":"publisher","first-page":"1170","DOI":"10.1016\/j.amjcard.2020.01.016","volume":"125","author":"F Fortuni","year":"2020","unstructured":"Fortuni F, Casula M, Sanzo A, Angelini F, Cornara S, Somaschini A, Mugnai G, Rordorf R, De Ferrari GM. Meta-analysis comparing cryoballoon versus radiofrequency as first ablation procedure for atrial fibrillation. Am J Cardiol. 2020;125(8):1170\u20139. https:\/\/doi.org\/10.1016\/j.amjcard.2020.01.016.","journal-title":"Am J Cardiol"},{"issue":"4","key":"1836_CR5","doi-asserted-by":"publisher","first-page":"359","DOI":"10.5114\/aic.2020.101760","volume":"16","author":"G Kie\u0142basa","year":"2020","unstructured":"Kie\u0142basa G, Jastrz\u0119bski M. Cryoballoon pulmonary vein isolation as a standard approach for interventional treatment of atrial fibrillation. A review and a practical guide to an effective and safe procedure. Postepy Kardiol Interwencyjnej. 2020;16(4):359\u201375. https:\/\/doi.org\/10.5114\/aic.2020.101760.","journal-title":"Postepy Kardiol Interwencyjnej"},{"issue":"4","key":"1836_CR6","doi-asserted-by":"publisher","first-page":"581","DOI":"10.1093\/europace\/euy239","volume":"21","author":"D M\u00f6rtsell","year":"2019","unstructured":"M\u00f6rtsell D, Arbelo E, Dagres N, Brugada J, Laroche C, Trines SA, Malmborg H, H\u00f6glund N, Tavazzi L, Pokushalov E, Stabile G, Blomstr\u00f6m-Lundqvist C, ESC-EHRA Atrial Fibrillation Ablation Long-Term Registry investigators. Cryoballoon vs radiofrequency ablation for atrial fibrillation: a study of outcome and safety based on the ESC-EHRA atrial fibrillation ablation long-term registry and the Swedish catheter ablation registry. Europace. 2019;21(4):581\u20139. https:\/\/doi.org\/10.1093\/europace\/euy239.","journal-title":"Europace."},{"unstructured":"Yacoub M, Sheppard RC. Cryoballoon pulmonary vein catheter ablation of atrial fibrillation. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023.","key":"1836_CR7"},{"unstructured":"Medtronic receives FDA expanded approval for Arctic FrontTM family of cardiac cryoablation catheters for initial use for recurrent symptomatic paroxysmal atrial fibrillation. Medtronic. 2021. https:\/\/news.medtronic.com\/2021-06-21-Medtronic-Receives-FDA-Expanded-Approval-for-Arctic-Front-TM-Family-of-Cardiac-Cryoablation-Catheters-for-Initial-Use-for-Recurrent-Symptomatic-Paroxysmal-Atrial-Fibrillation.\u00a0Accessed 29 May 2024.","key":"1836_CR8"},{"issue":"12","key":"1836_CR9","doi-asserted-by":"publisher","first-page":"1917","DOI":"10.1093\/europace\/euac148","volume":"24","author":"CH Heeger","year":"2022","unstructured":"Heeger CH, Pott A, Sohns C, Riesinger L, Sommer P, Gasperetti A, Tondo C, Fassini G, Moser F, Lucas P, Weinmann K, Bohnen JE, Dahme T, Rillig A, Kuck KH, Wakili R, Metzner A, Tilz RR. Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study. Europace. 2022;24(12):1917\u201325. https:\/\/doi.org\/10.1093\/europace\/euac148.","journal-title":"Europace"},{"issue":"9","key":"1836_CR10","doi-asserted-by":"publisher","first-page":"euad248","DOI":"10.1093\/europace\/euad248","volume":"25","author":"CH Heeger","year":"2023","unstructured":"Heeger CH, Popescu SS, Inderhees T, Nussbickel N, Eitel C, Kirstein B, Phan HL, Hatahet S, Subin B, Traub A, Gro\u00dfe N, Kuck KH, Vogler J, Tilz RR. Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study. Europace. 2023;25(9):euad248. https:\/\/doi.org\/10.1093\/europace\/euad248.","journal-title":"Europace"},{"issue":"4","key":"1836_CR11","doi-asserted-by":"publisher","first-page":"931","DOI":"10.1111\/jce.14953","volume":"32","author":"WW Su","year":"2021","unstructured":"Su WW. A second cryoballoon system-new and improved? J Cardiovasc Electrophysiol. 2021;32(4):931\u20132. https:\/\/doi.org\/10.1111\/jce.14953.","journal-title":"J Cardiovasc Electrophysiol"},{"key":"1836_CR12","doi-asserted-by":"publisher","first-page":"A12149","DOI":"10.1161\/circ.146.suppl_1.12149","volume":"146","author":"ED Tomaiko-Clark","year":"2022","unstructured":"Tomaiko-Clark ED, Weiss JP, Zawaneh M, Su W. Assessment of cryoballoon occlusion shift from the pulmonary vein ostium following freeze initiation using a dielectric imaging system. Circulation. 2022;146:A12149.","journal-title":"Circulation"},{"doi-asserted-by":"publisher","unstructured":"Liao Y, Tomaiko-Clark ED, Martinez J, Shinoda Y, Morris MF, Liu Z, Shatz DY, Katrapati P, Sahara N, Weiss JP, Zawaneh MS, Tung R, Bai R, Su W. Incidence of cryoballoon expansion dislodgement during pulmonary vein isolation-an underappreciated frequent cause of incomplete isolation. Pacing Clin Electrophysiol. 2023.\u00a0https:\/\/doi.org\/10.1111\/pace.14910.","key":"1836_CR13","DOI":"10.1111\/pace.14910"},{"issue":"4","key":"1836_CR14","doi-asserted-by":"publisher","first-page":"836","DOI":"10.1161\/CIRCEP.115.002725","volume":"8","author":"M Takami","year":"2015","unstructured":"Takami M, Lehmann HI, Misiri J, Parker KD, Sarmiento RI, Johnson SB, Packer DL. Impact of freezing time and balloon size on the thermodynamics and isolation efficacy during pulmonary vein isolation using the second generation cryoballoon. Circ Arrhythm Electrophysiol. 2015;8(4):836\u201345. https:\/\/doi.org\/10.1161\/CIRCEP.115.002725.","journal-title":"Circ Arrhythm Electrophysiol"},{"issue":"1","key":"1836_CR15","doi-asserted-by":"publisher","first-page":"186","DOI":"10.1161\/CIRCEP.114.002137","volume":"8","author":"M Takami","year":"2015","unstructured":"Takami M, Misiri J, Lehmann HI, Parker KD, Johnson SB, Sarmiento RI, Packer DL. Spatial and time-course thermodynamics during pulmonary vein isolation using the second-generation cryoballoon in a canine in vivo model. Circ Arrhythm Electrophysiol. 2015;8(1):186\u201392. https:\/\/doi.org\/10.1161\/CIRCEP.114.002137.","journal-title":"Circ Arrhythm Electrophysiol"},{"issue":"3","key":"1836_CR16","doi-asserted-by":"publisher","first-page":"353","DOI":"10.1016\/j.hrthm.2007.11.006","volume":"5","author":"VY Reddy","year":"2008","unstructured":"Reddy VY, Neuzil P, d\u2019Avila A, Laragy M, Malchano ZJ, Kralovec S, Kim SJ, Ruskin JN. Balloon catheter ablation to treat paroxysmal atrial fibrillation: what is the level of pulmonary venous isolation? Heart Rhythm. 2008;5(3):353\u201360. https:\/\/doi.org\/10.1016\/j.hrthm.2007.11.006.","journal-title":"Heart Rhythm"},{"issue":"9","key":"1836_CR17","doi-asserted-by":"publisher","first-page":"1348","DOI":"10.1016\/j.hrthm.2018.04.021","volume":"15","author":"W Su","year":"2018","unstructured":"Su W, Aryana A, Passman R, Singh G, Hokanson R, Kowalski M, Andrade J, Wang P. Cryoballoon Best Practices II: Practical guide to procedural monitoring and dosing during atrial fibrillation ablation from the perspective of experienced users. Heart Rhythm. 2018;15(9):1348\u201355. https:\/\/doi.org\/10.1016\/j.hrthm.2018.04.021.","journal-title":"Heart Rhythm"},{"issue":"10","key":"1836_CR18","doi-asserted-by":"publisher","first-page":"1676","DOI":"10.1093\/europace\/euw233","volume":"19","author":"B Reissmann","year":"2017","unstructured":"Reissmann B, Wissner E, Deiss S, Heeger C, Schlueter M, Wohlmuth P, Lemes C, Mathew S, Maurer T, Sohns C, Saguner A, Santoro F, Hayashi K, Riedl J, Ouyang F, Kuck KH, Metzner A. First insights into cryoballoon-based pulmonary vein isolation taking the individual time-to-isolation into account. Europace. 2017;19(10):1676\u201380. https:\/\/doi.org\/10.1093\/europace\/euw233.","journal-title":"Europace"},{"issue":"4","key":"1836_CR19","doi-asserted-by":"publisher","first-page":"495","DOI":"10.1016\/j.hrthm.2016.12.014","volume":"14","author":"KR Chun","year":"2017","unstructured":"Chun KR, Stich M, F\u00fcrnkranz A, Bordignon S, Perrotta L, Dugo D, Bologna F, Schmidt B. Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial. Heart Rhythm. 2017;14(4):495\u2013500. https:\/\/doi.org\/10.1016\/j.hrthm.2016.12.014.","journal-title":"Heart Rhythm"},{"issue":"12","key":"1836_CR20","doi-asserted-by":"publisher","first-page":"e005318","DOI":"10.1161\/CIRCEP.117.005318","volume":"10","author":"\u00c1 Ferrero-de-Loma-Osorio","year":"2017","unstructured":"Ferrero-de-Loma-Osorio \u00c1, Garc\u00eda-Fern\u00e1ndez A, Castillo-Castillo J, Izquierdo-de-Francisco M, Ib\u00e1\u00f1ez-Cr\u00edado A, Moreno-Arribas J, Mart\u00ednez A, Bertomeu-Gonz\u00e1lez V, L\u00f3pez-Mases P, Ajo-Ferrer M, N\u00fa\u00f1ez C, Bondanza-Saavedra L, S\u00e1nchez-G\u00f3mez JM, Mart\u00ednez-Mart\u00ednez JG, Chorro-Gasc\u00f3 FJ, Ruiz-Granell R. Time-to-effect-based dosing strategy for cryoballoon ablation in patients with paroxysmal atrial fibrillation: results of the plusONE multicenter randomized controlled noninferiority trial. Circ Arrhythm Electrophysiol. 2017;10(12):e005318. https:\/\/doi.org\/10.1161\/CIRCEP.117.005318.","journal-title":"Circ Arrhythm Electrophysiol"},{"issue":"9","key":"1836_CR21","doi-asserted-by":"publisher","first-page":"1319","DOI":"10.1016\/j.hrthm.2017.06.020","volume":"14","author":"A Aryana","year":"2017","unstructured":"Aryana A, Kenigsberg DN, Kowalski M, Koo CH, Lim HW, O\u2019Neill PG, Bowers MR, Hokanson RB, Ellenbogen KA, Cryo-DOSING Investigators. Verification of a novel atrial fibrillation cryoablation dosing algorithm guided by time-to-pulmonary vein isolation: results from the Cryo-DOSING study (cryoballoon-ablation DOSING based on the assessment of time-to-effect and pulmonary vein isolation guidance). Heart Rhythm. 2017;14(9):1319\u201325. https:\/\/doi.org\/10.1016\/j.hrthm.2017.06.020.","journal-title":"Heart Rhythm"},{"issue":"5","key":"1836_CR22","doi-asserted-by":"publisher","first-page":"1488","DOI":"10.21037\/jtd-22-418","volume":"14","author":"Y Xie","year":"2022","unstructured":"Xie Y, Guo R, Yan M, Zhao T, Xu Y, Zhao D. Effect of pulmonary vein cryoballoon ablation in dogs with coolant-nitrogen. J Thorac Dis. 2022;14(5):1488\u201396. https:\/\/doi.org\/10.21037\/jtd-22-418.","journal-title":"J Thorac Dis"},{"issue":"1","key":"1836_CR23","doi-asserted-by":"publisher","first-page":"e010516","DOI":"10.1161\/CIRCEP.121.010516","volume":"15","author":"CH Heeger","year":"2022","unstructured":"Heeger CH, Sohns C, Pott A, Metzner A, Inaba O, Straube F, Kuniss M, Aryana A, Miyazaki S, Cay S, Ehrlich JR, El-Battrawy I, Martinek M, Saguner AM, Tscholl V, Yalin K, Lyan E, Su W, Papiashvili G, Botros MSN, Gasperetti A, Proietti R, Wissner E, Scherr D, Kamioka M, Makimoto H, Urushida T, Aksu T, Chun JKR, Aytemir K, J\u0119drzejczyk-Patej E, Kuck KH, Dahme T, Steven D, Sommer P, Tilz RR. Phrenic nerve Injury during cryoballoon-based pulmonary vein isolation: results of the Worldwide YETI Registry. Circ Arrhythm Electrophysiol. 2022;15(1):e010516. https:\/\/doi.org\/10.1161\/CIRCEP.121.010516.","journal-title":"Circ Arrhythm Electrophysiol"},{"doi-asserted-by":"publisher","unstructured":"Yu L, Bai R, Shatz\u00a0DY, Katrapati P, Martinez J, Lockhart\u00a0C, Stempihar JM, Jones\u00a0C, Rodriguez\u00a0J,\u00a0 Zawaneh MS, Weiss JP, Tung R, Su WW. Quantifying procedural advantages of a novel variable size cryoballoon to optimize pulmonary vein isolation. Heart Rhythm. n.d.;20: S339\u201340. https:\/\/doi.org\/10.1016\/j.hrthm.2023.03.789.","key":"1836_CR24","DOI":"10.1016\/j.hrthm.2023.03.789"},{"doi-asserted-by":"publisher","unstructured":"Frommeyer G, Ellermann C, Wolfes J, Lange PS, G\u00fcner F, Eckardt L. Feasibility and efficacy of a novel size adjustable cryoballoon for ablation of atrial fibrillation. J Interv Card Electrophysiol. 2023. https:\/\/doi.org\/10.1007\/s10840-023-01645-2.","key":"1836_CR25","DOI":"10.1007\/s10840-023-01645-2"},{"issue":"1","key":"1836_CR26","doi-asserted-by":"publisher","first-page":"euad371","DOI":"10.1093\/europace\/euad371","volume":"26","author":"S Venier","year":"2023","unstructured":"Venier S, Vaxelaire N, Jacon P, Carabelli A, Desbiolles A, Garban F, Defaye P. Severe acute kidney injury related to haemolysis after pulsed field ablation for atrial fibrillation. Europace. 2023;26(1):euad371. https:\/\/doi.org\/10.1093\/europace\/euad371.","journal-title":"Europace"},{"issue":"24","key":"1836_CR27","doi-asserted-by":"publisher","first-page":"1808","DOI":"10.1161\/CIRCULATIONAHA.122.061497","volume":"146","author":"VY Reddy","year":"2022","unstructured":"Reddy VY, Petru J, Funasako M, Kopriva K, Hala P, Chovanec M, Janotka M, Kralovec S, Neuzil P. Coronary arterial spasm during pulsed field ablation to treat atrial fibrillation. Circulation. 2022;146(24):1808\u201319. https:\/\/doi.org\/10.1161\/CIRCULATIONAHA.122.061497.","journal-title":"Circulation."},{"doi-asserted-by":"publisher","unstructured":"Ruwald MH, Haugdal M, Worck R, Johannessen A, Hansen ML, S\u00f8rensen SK, Hansen J. Characterization of durability and reconnection patterns at time of repeat ablation after single-shot pulsed field pulmonary vein isolation. J Interv Card Electrophysiol. 2023. https:\/\/doi.org\/10.1007\/s10840-023-01655-0.","key":"1836_CR28","DOI":"10.1007\/s10840-023-01655-0"},{"doi-asserted-by":"publisher","unstructured":"Kueffer T, Stefanova A, Madaffari A, Seiler J, Thalmann G, Kozhuharov N, Maurhofer J, Galuszka O, Haeberlin A, Noti F, Servatius H, Tanner H, Roten L, Reichlin T. Pulmonary vein isolation durability and lesion regression in patients with recurrent arrhythmia after pulsed-field ablation. J Interv Card Electrophysiol. 2023. https:\/\/doi.org\/10.1007\/s10840-023-01608-7.","key":"1836_CR29","DOI":"10.1007\/s10840-023-01608-7"},{"doi-asserted-by":"publisher","unstructured":"Kueffer T, Bordignon S, Neven K, Blaauw Y, Hansen J, Adelino R, Ouss A, F\u00fcting A, Roten L, Mulder BA, Ruwald MH, Men\u00e9 R, van der Voort P, Reinsch N, Boveda S, Albrecht EM, Schneider CW, Chun KRJ, Schmidt B, Reichlin T. Durability of pulmonary vein isolation using pulsed-field ablation: results from the Multicenter EU-PORIA Registry. JACC Clin Electrophysiol. 2024;S2405-500X(23)00917-9.\u00a0https:\/\/doi.org\/10.1016\/j.jacep.2023.11.026.","key":"1836_CR30","DOI":"10.1016\/j.jacep.2023.11.026"}],"container-title":["Journal of Interventional Cardiac Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10840-024-01836-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10840-024-01836-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10840-024-01836-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,29]],"date-time":"2024-11-29T07:08:45Z","timestamp":1732864125000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10840-024-01836-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,3]]},"references-count":30,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2024,11]]}},"alternative-id":["1836"],"URL":"https:\/\/doi.org\/10.1007\/s10840-024-01836-5","relation":{},"ISSN":["1572-8595"],"issn-type":[{"type":"electronic","value":"1572-8595"}],"subject":[],"published":{"date-parts":[[2024,6,3]]},"assertion":[{"value":"11 March 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 May 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 June 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The histopathologic study performed by Horus Scientific (HS) was conducted in compliance with the United States Food and Drug Administration (FDA) Good Laboratory Practice (GLP) regulations, standards, and guidelines set forth in Title 21 of the Code of Federal Regulations (CFR) Part 58, except that Microsoft\u00ae Excel, a non-validated computer program, was used to capture histopathologic data and perform data calculations.The Synaptic Nordica Cryoablation System is currently being studied under the SENSATION IDE clinical study (NCT05905835): \u201cTreatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation with the Synaptic Compliant Cryoablation Balloon and System.\u201dThe study protocol was reviewed and approved by the T3 Labs Institutional Animal Care and Use Committee (IACUC) and by Designated Member Review (Study Code: SB01D).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Dr. Wilber Su and Dr. Xunzhang Wang received compensation as consultants of Synaptic Medical.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}