Atrial FibrillationNCT02752737
Cryo Global Registry
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 163 sites in 38 countries.
Trial summary
Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 5,385 participants
- Where
- 163 sitesin 38 countries
- Study dates
- 2 May 2016to 29 Nov 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 18 years or older with a planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter.
Who may be able to join
- Subject is ≥ 18 years of age or minimum age as required by local regulations
- Planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter
- Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Who cannot join
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
- Subject with exclusion criteria required by local law
Trial locations and contacts
163 sites in 38 countries.
163 sites in 38 countries
Japan61 sites
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki
Kansai Rosai Hospital
Amagasaki
Anjo Kosei Hospital
Anjo
Tokyo Medical and Dental University, Medical Hospital
Bunkyō City, 113-8519
Nippon Medical School Hospital
Bunkyō City
Tokyo University Hospital
Bunkyo-Ku, Tokyo, 113-8655
Chiba University Hospital
Chiba
Sakakibara Heart Institute
Fuchū, Tokyo, 183-0003
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, 814-0001
Tokai University Hachioji Hospital
Hachiōji
Saitama Medical University International Medical Center
Hidaka
Hirosaki University Hospital
Hirosaki, 036-8563
Hiroshima City Hospital
Hiroshima, Hiroshima, 730-8518
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Hiroshima City Hospital
Hiroshima
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Kanazawa University Hospital
Ishikawa
Nihon University Itabashi Hospital
Itabashi-ku
National Hospital Organization Kagoshima MC
Kagoshima
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
Kokura Kinen Hospital
Kitakyushu, 802-8555
Kobe City Medical Center General Hospital
Kobe, 650-0047
Dokkyo Medical University Saitama Medical Center
Koshigaya
Saiseikai Kumamoto Hospital
Kumamoto
Kyoto University Hospital
Kyoto, 606-8507
The Jikei University School of Medicine Hospital
Minatoku
Kyorin University Hospital
Mitaka
Mie Heart Center
Miwa
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, 880-0834
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650
Nagoya City University East Medical Center
Nagoya
Kochi Medical School Hospital
Nankoku
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502
Kurashiki Central Hospital
Okayama
Sakurabashi Watanabe Hospital
Osaka, Osaka, 530-0001
Kindai University Hospital
Ōsaka-sayama, 589-8511
Toho University Omori Medical Center
Ōta-ku
Kitasato University Hospital
Sagamihara
Japanese Red Cross Saitama Hospital
Saitama, 330-8553
Osaka Rosai Hospital
Sakai, Osaka, 591-8025
Hokkaido Ohno Memorial Hospital
Sapporo, Hokkaido, 063-0052
Caress Sapporo Hokko Memorial Hospital
Sapporo, Hokkaido, 065-0027
Sendai City Hospital
Sendai
Jichi Medical University Hospital
Shimotsuke-shi
National Cerebral and Cardiovascular Center
Suita
Osaka General Medical Center
Sumiyoshi-ku, Osaka, 558-8558
Tenri Hospital
Tenri
Showa University Toyosu Hospital
Tokyo, 135-8577
Tokyo Medical Center
Tokyo
Tokyo Metropolitan Hiroo Hospital
Tokyo
Toyama Prefectural Central Hospital
Toyama
Fujita Health University Hospital
Toyoake
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaraki, 300-0028
University of Tsukuba Hospital
Tsukuba
Japanese Red Cross Wakayama Medical Center
Wakayama, Kansai, 640-8558
Yamagata University Hospital
Yamagata, 990-9585
Yokkaichi Municipal Hospital
Yokkaichi
Yokohama City Minato Red Cross Hospital
Yokohama, 231-8682
University of Fukui Hospital
Yoshida
Germany13 sites
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, 29549
Segeberger Kliniken GmbH - Herzzentrum
Bad Segeberg, 23795
Sana Klinikum Lichtenberg
Berlin, 10365
Städtische Kliniken Bielefeld
Bielefeld, 33604
Klinikum Coburg GmbH
Coburg, 69450
St. Vinzenz-Hospital Köln
Cologne, 50733
Cardioangiologisches Centrum Bethanien
Frankfurt, 60389
Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid
Lüdenscheid, North Rhine-Westphalia, 58515
Klinikum Lüdenscheid
Lüdenscheid, 58515
Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus
Mönchengladbach, 41063
Städtische Kliniken München GmbH - Klinikum Bogenhausen
München
Oberschwaben-Klinik GmbH - Krankenhaus St. Elisabeth
Ravensburg, 88212
St. Josephs Hospital Wiesbaden
Wiesbaden, 65189
United States6 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852
The Lindner Research Center
Cincinnati, Ohio, 45219
Texas Health Research & Education Institute
Dallas, Texas, 75231
Doylestown Health Cardiology
Doylestown, Pennsylvania, 18901
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503-2560
Carle Foundation Hospital
Urbana, Illinois, 61801
China6 sites
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
West China Hospital of Sichuan University
Chengdu, 610041
Shanghai Tenth People's Hospital
Shanghai, 200072
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Tianjin Chest Hospital
Tianjin, 300051
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
India6 sites
Apollo Hospital (Chennai)
Chennai, Tamil Nadu, 600006
Aig Hospital
Hyderabad
Eternal Hospital
Jaipur, Rajasthan, 302017
Aster Medcity
Kochi, Kerala, 682027
Max Super Speciality Hospital
New Delhi, 110017
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Thiruvananthapuram, Kerala, 695011
United Kingdom5 sites
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE
St George's University Hospitals - NHS Trust
London, SW17 0QT
St. George's Hospital-NHS Trust
London, SW17 0QT
St. Bartholomew's Hospital
London
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Italy4 sites
Humanitas Mater Domini
Castellanza, 21053
Fondazione IRCCS Policlinico San
Pavia
Ospedale S. Maria della Misericordia
Perugia, 06129
Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
Pisa, 56100
Malaysia4 sites
Cardiac Vascular Sentral Kuala Lumpur (CVSKL)
Kuala Lumpur, Malaysia, 50470
Institut Jantung Negara
Kuala Lumpur, 50400
Sarawak Heart Centre
Kuching, Sarawak, 94300
Hospital Serdang
Sepang, Selangor, 43000
Poland4 sites
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz
Spital Wojewodzki nr 2
Rzeszów, Poland, 35-301
Kliniczny Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie
Rzeszów
Taiwan4 sites
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Mackay Memorial Hospital
Taipei, Taiwan, 10491
Cheng-Hsin General Hospital
Taipei, Taiwan, 112
Taipei Veterans General Hospital
Taipei
Argentina3 sites
Instituto Cardiovascular de Buenos Aires (ICBA)
Buenos Aires, C1428DCO
Institituo Cardiovascular Buenos Aires (ICBA)
Buenos Aires, CP:1428
Hospital Universitario Fundación Favaloro
Buenos Aires
Mexico3 sites
Hospital Angeles Lomas
Huixquilucan, State of Mexico, 52763
Hospital San Angel Inn Universidad
México, 03330
Centro Médico Nacional Siglo XXI
Mexico City, 06720
Russia3 sites
Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
Moscow
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk
State Budgetary Healthcare Institution of Sverdlovsk region for "Sverdlovsk Regional Clinical Hospital #1"
Yekaterinburg, 620102
Singapore3 sites
National University Hospital
Singapore, 119074
National Heart Centre Singapore
Singapore, 169609
National University Hospital
Singapore
Slovakia3 sites
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banská Bystrica, 97401
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
Bratislava, 83348
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
Košice, 04011
South Korea3 sites
Seoul National University Bundang Hospital
Seoul, Gyeonggi-do, 463-707
Hallym University Sacred Heart Hospital
Seoul, 152-703
Samsung Medical Center
Seoul
Thailand3 sites
Siriraj Hospital
Bangkok, Thailand, 10700
Phramongkutklao Hospital
Bangkok
Ramathibodi Hospital
Bangkok
Belgium2 sites
Onze-Lieve-Vrouwziekenhuis-Campus Aalst
Aalst
Centre Hospitalier Régional de la Citadelle
Liège, Liege, 4000
Hungary2 sites
Gottsegen György Országos Kardiológiai Intézet
Budapest
Debreceni Egyetem
Debrecen
Indonesia2 sites
National Cardiovascular Center Harapan Kita
Jakarta, 11420
National Cardiovascular Center Harapan Kita
Jakarta
Kuwait2 sites
Salman Al Abdallah Al Dabbous Cardiac Center (DCC) - Al Adan Hospital
Al Ahmadi
Chest Diseases Hospital
Kuwait City
Philippines2 sites
Saint Lukes Medical Center (SLMC)
City of Taguig, National Capital Region, 1634
The Medical City
Pasig, National Capital Region, 1603
South Africa2 sites
Netcare Sunninghill Hospital
Johannesburg
Busamed Gateway Hospital
Umhlanga, 4319
United Arab Emirates2 sites
Cleveland Clinic Abu Dhabi
Abu Dhabi
Sheikh Khalifa Medical City
Abu Dhabi
Brunei1 site
Gleneagles Jerudong Park Medical Centre
Bandar Seri Begawan, Brunei, BG3122
Iceland1 site
Landspitali - National Hospital of Iceland
Reykjavik, Iceland, 108
Portugal1 site
Centro hospitalar Vila Nova de Gaia/Espinho-Unidade I
Vila Nova de Gaia, 4434-502
Serbia1 site
Institute for Cardiovascular Disease (ICVD) Dedinje
Belgrade, Serbia, 11040
About this study
Official title: Cryo Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry
Read the detailed description
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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 Months
Freedom from Arrythmias at 12 months
Estimate the 12-month freedom from arrythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start2 May 2016
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,385 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khaldoun Tarakji, MD, Study director, Medtronic CAS Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752737
- Sponsor's protocol ID
- Cryo Global Registry
- Status last verified
- Feb 2025
- First submitted
- 25 Apr 2016
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 41727702Abdrakhmanov 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.
PubMed 40545038Khelae 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.
PubMed 40529551Lawin 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.
PubMed 39836630Foldesi 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.
PubMed 39136617Ahn 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.
PubMed 38956935Lawin 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.
PubMed 38082096Scazzuso 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.
PubMed 37505337Zucchelli 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.
PubMed 36331681Lim 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.
PubMed 36097833Rordorf 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.
PubMed 34889108
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryo Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
- ClinicalTrials.gov ID
- NCT02752737
- Acronym / sponsor ID
- Cryo Global Registry
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,385 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 2 May 2016 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years or older with a planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter.
Key inclusion criteria (3 listed)
- Subject is ≥ 18 years of age or minimum age as required by local regulations
- Planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter
- Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Key exclusion criteria (2 listed)
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
- Subject with exclusion criteria required by local law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months
Time frame: 12 Months
Estimate the 12 month freedom from AF recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System
Freedom from Atrial Arrhythmia at 12 Months
Time frame: 12 Months
Estimate the 12 month freedom from AF / Atrial Flutter (AFL)/ Atrial Tachycardia (AT) using the Arctic Front™ Cardiac Cryoablation Catheter System.
Freedom from Arrythmias at 12 months
Time frame: 12 Months
Estimate the 12-month freedom from arrythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters.
Freedom from Device / Procedure Related Adverse Events
Time frame: 12 Months
Estimate device and procedure-related adverse events for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 41727702Fukunaga 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.
- Derived from this study: PubMed 40545038Abdrakhmanov 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.
- Derived from this study: PubMed 40529551Khelae 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.
- Derived from this study: PubMed 39836630Lawin 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.
- Derived from this study: PubMed 39136617Foldesi 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.
- Derived from this study: PubMed 38956935Ahn 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.
- Derived from this study: PubMed 38082096Lawin 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.
- Derived from this study: PubMed 37505337Scazzuso 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.
- Derived from this study: PubMed 36331681Zucchelli 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.
- Derived from this study: PubMed 36097833Lim 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.
- Derived from this study: PubMed 34889108Rordorf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaldoun Tarakji, MD study director
Medtronic CAS Chief Medical Officer
163 sites in 38 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 163 sites in 38 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 163 sites in Japan, Germany, United States, China, India and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752737, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.