CClinicalTrials.gg
CompletedNCT02752737Updated Jul 30, 2025

Cryo Global Registry

An observational study in Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions. Completed at 163 sites in 38 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by Medtronic Cardiac Ablation Solutions · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,385
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 5,385 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Medtronic Cardiac Ablation Solutions is the lead sponsor of 37 studies on the registry; 10 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects 18 years or older with a planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,385 participants (actual)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 Months

  2. 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.

    Time frame: 12 Months

  3. Freedom from Arrythmias at 12 months

    Estimate the 12-month freedom from arrythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters.

    Time frame: 12 Months

  4. 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.

    Time frame: 12 Months

07

Study locations

163 sites
  • Carle Foundation Hospital
    Urbana, Illinois 61801, United States
  • Spectrum Health Hospitals
    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

Showing the first 100 of 163 sites across 38 countries.

08

References and documents

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 41727702 ↗
  • 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. PubMed 40545038 ↗
  • 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. PubMed 40529551 ↗
  • 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. PubMed 39836630 ↗
  • 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. PubMed 39136617 ↗
  • 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. PubMed 38956935 ↗
  • 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. PubMed 38082096 ↗
  • 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. PubMed 37505337 ↗
  • 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. PubMed 36331681 ↗
  • 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. PubMed 36097833 ↗
  • 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. PubMed 34889108 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02752737
Lead sponsor
Medtronic Cardiac Ablation Solutions
Responsible party
Sponsor
First posted
Apr 27, 2016
Start date
May 2, 2016
Primary completion
Nov 29, 2024
Completion
Nov 29, 2024
Last update
Jul 30, 2025

Study contacts

Khaldoun Tarakji, MD
study director · Medtronic CAS Chief Medical Officer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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