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Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry
The Cryo Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to evaluate and describe clinical performance and safety data in a broad patient population treated with a commercially available Arctic Front™ Family of Cardiac Cryoablation Catheters (hereafter referred to as "Arctic Front™ Cardiac Cryoablation Catheter System"). The cryoballoon ablation(CBA) procedure will be performed according to routine hospital practice. The study is expected to have a 24 month enrollment period. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.
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| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months | Estimate the 12 month freedom from AF recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System | 12 Months |
| Freedom from Atrial Arrhythmia at 12 Months | Estimate the 12 month freedom from AF / Atrial Flutter (AFL)/ Atrial Tachycardia (AT) using the Arctic Front™ Cardiac Cryoablation Catheter System. | 12 Months |
| Freedom from Arrythmias at 12 months | Estimate the 12-month freedom from arrythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters. | 12 Months |
| Freedom from Device / Procedure Related Adverse Events | Estimate device and procedure-related adverse events for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12 months. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 18 years or older with a planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter.
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| Name | Affiliation | Role |
|---|---|---|
| Khaldoun Tarakji, MD | Medtronic CAS Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States | ||
| Spectrum Health Hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41727702 | Derived | Fukunaga H, Murakami M, Yoshida Y, Inaba O, Miura F, Yamauchi Y, Shizuta S, Yagishita A, Kumagai K, Nakahara S, Egami Y, Sawhney N, Obidigbo V, Ando K, Nitta J; Cryo Global Registry. Cryoballoon Ablation for Persistent Atrial Fibrillation in Japan: Cryo Global Registry 12-Months Results. J Arrhythm. 2026 Feb 19;42(1):e70291. doi: 10.1002/joa3.70291. eCollection 2026 Feb. | |
| 40545038 |
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| Grand Rapids |
| Michigan |
| 49503-2560 |
| United States |
| The Lindner Research Center | Cincinnati | Ohio | 45219 | United States |
| Doylestown Health Cardiology | Doylestown | Pennsylvania | 18901 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705-1852 | United States |
| Texas Health Research & Education Institute | Dallas | Texas | 75231 | United States |
| Instituto Cardiovascular de Buenos Aires (ICBA) | Buenos Aires | C1428DCO | Argentina |
| Institituo Cardiovascular Buenos Aires (ICBA) | Buenos Aires | CP:1428 | Argentina |
| Hospital Universitario Fundación Favaloro | Buenos Aires | Argentina |
| Kepler Universitätsklinikum Med Campus III. | Linz | 4021 | Austria |
| Centre Hospitalier Régional de la Citadelle | Liège | Liege | 4000 | Belgium |
| Onze-Lieve-Vrouwziekenhuis-Campus Aalst | Aalst | Belgium |
| Gleneagles Jerudong Park Medical Centre | Bandar Seri Begawan | Brunei | BG3122 | Brunei |
| Clínica Dávila | Santiago | Chile |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | 100037 | China |
| West China Hospital of Sichuan University | Chengdu | 610041 | China |
| Shanghai Tenth People's Hospital | Shanghai | 200072 | China |
| Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | China |
| Tianjin Chest Hospital | Tianjin | 300051 | China |
| Fundacion Clinica Shaio | Bogotá | Colombia |
| Clinica Ces | Medellín | Colombia |
| Nemocnice Na Homolce | Prague | 150 30 | Czechia |
| Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid | Lüdenscheid | North Rhine-Westphalia | 58515 | Germany |
| Herz- und Gefässzentrum Bad Bevensen | Bad Bevensen | 29549 | Germany |
| Segeberger Kliniken GmbH - Herzzentrum | Bad Segeberg | 23795 | Germany |
| Sana Klinikum Lichtenberg | Berlin | 10365 | Germany |
| Städtische Kliniken Bielefeld | Bielefeld | 33604 | Germany |
| Klinikum Coburg GmbH | Coburg | 69450 | Germany |
| St. Vinzenz-Hospital Köln | Cologne | 50733 | Germany |
| Cardioangiologisches Centrum Bethanien | Frankfurt | 60389 | Germany |
| Klinikum Lüdenscheid | Lüdenscheid | 58515 | Germany |
| Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus | Mönchengladbach | 41063 | Germany |
| Städtische Kliniken München GmbH - Klinikum Bogenhausen | München | Germany |
| Oberschwaben-Klinik GmbH - Krankenhaus St. Elisabeth | Ravensburg | 88212 | Germany |
| St. Josephs Hospital Wiesbaden | Wiesbaden | 65189 | Germany |
| Hellenic Airforce 251 General Hospital | Athens | 11525 | Greece |
| Gottsegen György Országos Kardiológiai Intézet | Budapest | Hungary |
| Debreceni Egyetem | Debrecen | Hungary |
| Landspitali - National Hospital of Iceland | Reykjavik | Iceland | 108 | Iceland |
| Aster Medcity | Kochi | Kerala | 682027 | India |
| Sree Chitra Tirunal Institute for Medical Sciences & Technology | Thiruvananthapuram | Kerala | 695011 | India |
| Eternal Hospital | Jaipur | Rajasthan | 302017 | India |
| Apollo Hospital (Chennai) | Chennai | Tamil Nadu | 600006 | India |
| Aig Hospital | Hyderabad | India |
| Max Super Speciality Hospital | New Delhi | 110017 | India |
| National Cardiovascular Center Harapan Kita | Jakarta | 11420 | Indonesia |
| National Cardiovascular Center Harapan Kita | Jakarta | Indonesia |
| Humanitas Mater Domini | Castellanza | 21053 | Italy |
| Fondazione IRCCS Policlinico San | Pavia | Italy |
| Ospedale S. Maria della Misericordia | Perugia | 06129 | Italy |
| Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello | Pisa | 56100 | Italy |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan |
| Japanese Red Cross Nagoya Daini Hospital | Nagoya | Aichi-ken | 466-8650 | Japan |
| Fukuoka Sanno Hospital | Fukuoka | Fukuoka | 814-0001 | Japan |
| Ogaki Municipal Hospital | Ōgaki | Gifu | 503-8502 | Japan |
| Hiroshima City Hospital | Hiroshima | Hiroshima | 730-8518 | Japan |
| Hiroshima Prefectural Hospital | Hiroshima | Hiroshima | 734-8530 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Hokkaido Ohno Memorial Hospital | Sapporo | Hokkaido | 063-0052 | Japan |
| Caress Sapporo Hokko Memorial Hospital | Sapporo | Hokkaido | 065-0027 | Japan |
| Tsuchiura Kyodo General Hospital | Tsuchiura | Ibaraki | 300-0028 | Japan |
| Tokai University Hospital | Isehara | Kanagawa | 259-1193 | Japan |
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | 247-8533 | Japan |
| Japanese Red Cross Wakayama Medical Center | Wakayama | Kansai | 640-8558 | Japan |
| Miyazaki Medical Association Hospital | Miyazaki | Miyazaki | 880-0834 | Japan |
| Sakurabashi Watanabe Hospital | Osaka | Osaka | 530-0001 | Japan |
| Osaka Rosai Hospital | Sakai | Osaka | 591-8025 | Japan |
| Osaka General Medical Center | Sumiyoshi-ku | Osaka | 558-8558 | Japan |
| Tokyo University Hospital | Bunkyo-Ku | Tokyo | 113-8655 | Japan |
| Sakakibara Heart Institute | Fuchū | Tokyo | 183-0003 | Japan |
| Hyogo Prefectural Amagasaki General Medical Center | Amagasaki | Japan |
| Kansai Rosai Hospital | Amagasaki | Japan |
| Anjo Kosei Hospital | Anjo | Japan |
| Tokyo Medical and Dental University, Medical Hospital | Bunkyō City | 113-8519 | Japan |
| Nippon Medical School Hospital | Bunkyō City | Japan |
| Chiba University Hospital | Chiba | Japan |
| Tokai University Hachioji Hospital | Hachiōji | Japan |
| Saitama Medical University International Medical Center | Hidaka | Japan |
| Hirosaki University Hospital | Hirosaki | 036-8563 | Japan |
| Hiroshima City Hospital | Hiroshima | Japan |
| Kanazawa University Hospital | Ishikawa | Japan |
| Nihon University Itabashi Hospital | Itabashi-ku | Japan |
| National Hospital Organization Kagoshima MC | Kagoshima | Japan |
| Kokura Kinen Hospital | Kitakyushu | 802-8555 | Japan |
| Kobe City Medical Center General Hospital | Kobe | 650-0047 | Japan |
| Dokkyo Medical University Saitama Medical Center | Koshigaya | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| The Jikei University School of Medicine Hospital | Minatoku | Japan |
| Kyorin University Hospital | Mitaka | Japan |
| Mie Heart Center | Miwa | Japan |
| Nagoya City University East Medical Center | Nagoya | Japan |
| Kochi Medical School Hospital | Nankoku | Japan |
| Kurashiki Central Hospital | Okayama | Japan |
| Kindai University Hospital | Ōsaka-sayama | 589-8511 | Japan |
| Toho University Omori Medical Center | Ōta-ku | Japan |
| Kitasato University Hospital | Sagamihara | Japan |
| Japanese Red Cross Saitama Hospital | Saitama | 330-8553 | Japan |
| Sendai City Hospital | Sendai | Japan |
| Jichi Medical University Hospital | Shimotsuke-shi | Japan |
| National Cerebral and Cardiovascular Center | Suita | Japan |
| Tenri Hospital | Tenri | Japan |
| Showa University Toyosu Hospital | Tokyo | 135-8577 | Japan |
| Tokyo Medical Center | Tokyo | Japan |
| Tokyo Metropolitan Hiroo Hospital | Tokyo | Japan |
| Toyama Prefectural Central Hospital | Toyama | Japan |
| Fujita Health University Hospital | Toyoake | Japan |
| University of Tsukuba Hospital | Tsukuba | Japan |
| Yamagata University Hospital | Yamagata | 990-9585 | Japan |
| Yokkaichi Municipal Hospital | Yokkaichi | Japan |
| Yokohama City Minato Red Cross Hospital | Yokohama | 231-8682 | Japan |
| University of Fukui Hospital | Yoshida | Japan |
| National Research Cardiac Surgery Center | Astana | Kazakhstan |
| Salman Al Abdallah Al Dabbous Cardiac Center (DCC) - Al Adan Hospital | Al Ahmadi | Kuwait |
| Chest Diseases Hospital | Kuwait City | Kuwait |
| Cardiac Vascular Sentral Kuala Lumpur (CVSKL) | Kuala Lumpur | Malaysia | 50470 | Malaysia |
| Sarawak Heart Centre | Kuching | Sarawak | 94300 | Malaysia |
| Hospital Serdang | Sepang | Selangor | 43000 | Malaysia |
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| Hospital Angeles Lomas | Huixquilucan | State of Mexico | 52763 | Mexico |
| Centro Médico Nacional Siglo XXI | Mexico City | 06720 | Mexico |
| Hospital San Angel Inn Universidad | México | 03330 | Mexico |
| The Royal Hospital | Muscat | Oman |
| Saint Lukes Medical Center (SLMC) | City of Taguig | National Capital Region | 1634 | Philippines |
| The Medical City | Pasig | National Capital Region | 1603 | Philippines |
| Spital Wojewodzki nr 2 | Rzeszów | Poland | 35-301 | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II | Krakow | Poland |
| Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi | Lodz | Poland |
| Kliniczny Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie | Rzeszów | Poland |
| Centro hospitalar Vila Nova de Gaia/Espinho-Unidade I | Vila Nova de Gaia | 4434-502 | Portugal |
| Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN | Moscow | Russia |
| Tomsk National Research Medical Center of the Russian Academy of Sciences | Tomsk | Russia |
| State Budgetary Healthcare Institution of Sverdlovsk region for "Sverdlovsk Regional Clinical Hospital #1" | Yekaterinburg | 620102 | Russia |
| King Fahad Medical City (KFMC) | Riyadh | 11433 | Saudi Arabia |
| Institute for Cardiovascular Disease (ICVD) Dedinje | Belgrade | Serbia | 11040 | Serbia |
| National University Hospital | Singapore | 119074 | Singapore |
| National Heart Centre Singapore | Singapore | 169609 | Singapore |
| National University Hospital | Singapore | Singapore |
| Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s | Banská Bystrica | 97401 | Slovakia |
| Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH) | Bratislava | 83348 | Slovakia |
| Vychodoslovensky ustav srdcovych a cievnych chorob, a.s. | Košice | 04011 | Slovakia |
| Netcare Sunninghill Hospital | Johannesburg | South Africa |
| Busamed Gateway Hospital | Umhlanga | 4319 | South Africa |
| Seoul National University Bundang Hospital | Seoul | Gyeonggi-do | 463-707 | South Korea |
| Hallym University Sacred Heart Hospital | Seoul | 152-703 | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Hospital Universitario Moncloa | Madrid | 28008 | Spain |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
| Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | Taiwan |
| Mackay Memorial Hospital | Taipei | Taiwan | 10491 | Taiwan |
| Cheng-Hsin General Hospital | Taipei | Taiwan | 112 | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Siriraj Hospital | Bangkok | Thailand | 10700 | Thailand |
| Phramongkutklao Hospital | Bangkok | Thailand |
| Ramathibodi Hospital | Bangkok | Thailand |
| Cleveland Clinic Abu Dhabi | Abu Dhabi | United Arab Emirates |
| Sheikh Khalifa Medical City | Abu Dhabi | United Arab Emirates |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital | Newcastle upon Tyne | United Kingdom | NE7 7DN | United Kingdom |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | L14 3PE | United Kingdom |
| St George's University Hospitals - NHS Trust | London | SW17 0QT | United Kingdom |
| St. George's Hospital-NHS Trust | London | SW17 0QT | United Kingdom |
| St. Bartholomew's Hospital | London | United Kingdom |
| Derived |
| Abdrakhmanov A, Nuralinov O, Rashbayeva G, Tursunbekov A, Bagibayev S, Bakytzhanuly A, Yessilbayev Z, Chinybayeva A, Abdrakhmanova Z, Salustri A, Suleymen Z, Kirkimbayeva R. Cryoballoon ablation for the treatment of atrial fibrillation in Kazakhstan: One year outcome from the Cryo Global Registry. Indian Pacing Electrophysiol J. 2025 Sep-Oct;25(5):294-301. doi: 10.1016/j.ipej.2025.06.008. Epub 2025 Jun 20. |
| 40529551 | Derived | Khelae SK, Chun KRJ, Drephal C, Scazzuso F, Kueffer FJ, van Bragt KA, Lawrenz T, Todd D, Ptaszynski P, Foldesi C. Real-world sex differences in healthcare utilization after cryoballoon ablation: 2-year outcomes from the Cryo Global Registry. Front Cardiovasc Med. 2025 Jun 3;12:1549002. doi: 10.3389/fcvm.2025.1549002. eCollection 2025. |
| 39836630 | Derived | Lawin D, Stellbrink C, Chun KJ, Li CH, van Bragt KA, Kueffer F, Selma JM, Oh IY, Herzet JM, Nitta J, Chang TY, Lawrenz T. Impact of atrial fibrillation diagnosis-to-ablation time on 24-month efficacy and safety outcomes in the Cryo Global Registry. Europace. 2025 Feb 5;27(2):euaf008. doi: 10.1093/europace/euaf008. |
| 39136617 | Derived | Foldesi C, Kojic D, Sudzinova A, Kuniewicz M, Neuzil P, Csanadi Z, Skamla M, Svetlosak M, Romanek J, Holbrook R, Stefanic M, Sale A, Holmes TR, Ptaszynski P. Electrophysiology lab efficiency using cryoballoon for pulmonary vein isolation in central and eastern Europe: A sub-analysis of the cryo global registry study. Cardiol J. 2024;31(5):656-664. doi: 10.5603/cj.98292. Epub 2024 Aug 13. |
| 38956935 | Derived | Ahn H, Lim HE, On YK, Selma JM, Kueffer FJ, van Bragt KA, Obidigbo V, Oh IY. Long-term Outcome of Cryoballoon Ablation in Korean Patients With Atrial Fibrillation: Real-World Experience From the Cryo Global Registry. Korean Circ J. 2024 Oct;54(10):619-633. doi: 10.4070/kcj.2024.0044. Epub 2024 Jun 10. |
| 38082096 | Derived | Lawin D, Lawrenz T, Chun KRJ, Lim HE, Obidigbo V, Selma JM, Peytchev P, Nguyen DQ, Foldesi C, Stellbrink C; the Cryo AF Global Registry Investigators. Cryoballoon ablation of atrial fibrillation in octogenarians: one year outcomes from the cryo global registry. J Interv Card Electrophysiol. 2024 Sep;67(6):1341-1351. doi: 10.1007/s10840-023-01680-z. Epub 2023 Dec 12. |
| 37505337 | Derived | Scazzuso F, Ptaszynski P, Kaczmarek K, Chun KRJ, Khelae SK, Foldesi C, Obidigbo V, van Bragt KA, On YK, Al-Kandari F, Okumura K; Cryo Global Registry Investigators. Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation in the cryo global registry. J Interv Card Electrophysiol. 2024 Apr;67(3):493-501. doi: 10.1007/s10840-023-01582-0. Epub 2023 Jul 28. |
| 36331681 | Derived | Zucchelli G, Chun KRJ, Khelae SK, Foldesi C, Kueffer FJ, van Bragt KA, Scazzuso F, On YK, Al-Kandari F, Okumura K; Cryo Global Registry Investigators. Impact of first-line cryoablation for atrial fibrillation on healthcare utilization, arrhythmia disease burden and efficacy outcomes: real-world evidence from the Cryo Global Registry. J Interv Card Electrophysiol. 2023 Apr;66(3):711-722. doi: 10.1007/s10840-022-01388-6. Epub 2022 Nov 4. |
| 36097833 | Derived | Lim HE, Oh IY, Kueffer FJ, van Bragt KA, On YK. Cryoballoon Catheter Ablation in Korean Patients With Paroxysmal and Persistent Atrial Fibrillation: One Year Outcome From the Cryo Global Registry. Korean Circ J. 2022 Oct;52(10):755-767. doi: 10.4070/kcj.2022.0127. Epub 2022 Aug 12. |
| 34889108 | Derived | Rordorf R, Scazzuso F, Chun KRJ, Khelae SK, Kueffer FJ, Braegelmann KM, Okumura K, Al-Kandari F, On YK, Foldesi C; Cryo AF Global Registry Investigators. Cryoballoon Ablation for the Treatment of Atrial Fibrillation in Patients With Concomitant Heart Failure and Either Reduced or Preserved Left Ventricular Ejection Fraction: Results From the Cryo AF Global Registry. J Am Heart Assoc. 2021 Dec 21;10(24):e021323. doi: 10.1161/JAHA.121.021323. Epub 2021 Dec 10. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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