Cryo Global Registry

NCT ID: NCT02752737

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5385 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-02
• Study Completion Date: 2024-11-29

Brief Summary

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khaldoun Tarakji, MD

Role: STUDY_DIRECTOR

Medtronic CAS Chief Medical Officer

Locations

Carle Foundation Hospital

Urbana, Illinois, United States

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

The Lindner Research Center

Cincinnati, Ohio, United States

Doylestown Health Cardiology

Doylestown, Pennsylvania, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Texas Health Research & Education Institute

Dallas, Texas, United States

Instituto Cardiovascular de Buenos Aires (ICBA)

Buenos Aires, , Argentina

Institituo Cardiovascular Buenos Aires (ICBA)

Buenos Aires, , Argentina

Hospital Universitario Fundación Favaloro

Buenos Aires, , Argentina

Kepler Universitätsklinikum Med Campus III.

Linz, , Austria

Centre Hospitalier Régional de la Citadelle

Liège, Liege, Belgium

Onze-Lieve-Vrouwziekenhuis-Campus Aalst

Aalst, , Belgium

Gleneagles Jerudong Park Medical Centre

Bandar Seri Begawan, Brunei, Brunei

Clínica Dávila

Santiago, , Chile

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, , China

West China Hospital of Sichuan University

Chengdu, , China

Shanghai Tenth People's Hospital

Shanghai, , China

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Tianjin Chest Hospital

Tianjin, , China

Fundacion Clinica Shaio

Bogotá, , Colombia

Clinica Ces

Medellín, , Colombia

Nemocnice Na Homolce

Prague, , Czechia

Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid

Lüdenscheid, North Rhine-Westphalia, Germany

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, , Germany

Segeberger Kliniken GmbH - Herzzentrum

Bad Segeberg, , Germany

Sana Klinikum Lichtenberg

Berlin, , Germany

Städtische Kliniken Bielefeld

Bielefeld, , Germany

Klinikum Coburg GmbH

Coburg, , Germany

St. Vinzenz-Hospital Köln

Cologne, , Germany

Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

Klinikum Lüdenscheid

Lüdenscheid, , Germany

Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus

Mönchengladbach, , Germany

Städtische Kliniken München GmbH - Klinikum Bogenhausen

München, , Germany

Oberschwaben-Klinik GmbH - Krankenhaus St. Elisabeth

Ravensburg, , Germany

St. Josephs Hospital Wiesbaden

Wiesbaden, , Germany

Hellenic Airforce 251 General Hospital

Athens, , Greece

Gottsegen György Országos Kardiológiai Intézet

Budapest, , Hungary

Debreceni Egyetem

Debrecen, , Hungary

Landspitali - National Hospital of Iceland

Reykjavik, Iceland, Iceland

Aster Medcity

Kochi, Kerala, India

Sree Chitra Tirunal Institute for Medical Sciences & Technology

Thiruvananthapuram, Kerala, India

Eternal Hospital

Jaipur, Rajasthan, India

Apollo Hospital (Chennai)

Chennai, Tamil Nadu, India

Aig Hospital

Hyderabad, , India

Max Super Speciality Hospital

New Delhi, , India

National Cardiovascular Center Harapan Kita

Jakarta, , Indonesia

National Cardiovascular Center Harapan Kita

Jakarta, , Indonesia

Humanitas Mater Domini

Castellanza, , Italy

Fondazione IRCCS Policlinico San

Pavia, , Italy

Ospedale S. Maria della Misericordia

Perugia, , Italy

Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello

Pisa, , Italy

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Japanese Red Cross Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

Fukuoka Sanno Hospital

Fukuoka, Fukuoka, Japan

Ogaki Municipal Hospital

Ōgaki, Gifu, Japan

Hiroshima City Hospital

Hiroshima, Hiroshima, Japan

Hiroshima Prefectural Hospital

Hiroshima, Hiroshima, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Hokkaido Ohno Memorial Hospital

Sapporo, Hokkaido, Japan

Caress Sapporo Hokko Memorial Hospital

Sapporo, Hokkaido, Japan

Tsuchiura Kyodo General Hospital

Tsuchiura, Ibaraki, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Japanese Red Cross Wakayama Medical Center

Wakayama, Kansai, Japan

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, Japan

Sakurabashi Watanabe Hospital

Osaka, Osaka, Japan

Osaka Rosai Hospital

Sakai, Osaka, Japan

Osaka General Medical Center

Sumiyoshi-ku, Osaka, Japan

Tokyo University Hospital

Bunkyo-Ku, Tokyo, Japan

Sakakibara Heart Institute

Fuchū, Tokyo, 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, , 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, , 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, , Japan

Kobe City Medical Center General Hospital

Kobe, , Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, , Japan

Saiseikai Kumamoto Hospital

Kumamoto, , Japan

Kyoto University Hospital

Kyoto, , 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, , Japan

Toho University Omori Medical Center

Ōta-ku, , Japan

Kitasato University Hospital

Sagamihara, , Japan

Japanese Red Cross Saitama Hospital

Saitama, , 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, , 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, , Japan

Yokkaichi Municipal Hospital

Yokkaichi, , Japan

Yokohama City Minato Red Cross Hospital

Yokohama, , 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, Malaysia

Sarawak Heart Centre

Kuching, Sarawak, Malaysia

Hospital Serdang

Sepang, Selangor, Malaysia

Institut Jantung Negara

Kuala Lumpur, , Malaysia

Hospital Angeles Lomas

Huixquilucan, State of Mexico, Mexico

Centro Médico Nacional Siglo XXI

Mexico City, , Mexico

Hospital San Angel Inn Universidad

México, , Mexico

The Royal Hospital

Muscat, , Oman

Saint Lukes Medical Center (SLMC)

City of Taguig, National Capital Region, Philippines

The Medical City

Pasig, National Capital Region, Philippines

Spital Wojewodzki nr 2

Rzeszów, Poland, 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, , 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, , Russia

King Fahad Medical City (KFMC)

Riyadh, , Saudi Arabia

Institute for Cardiovascular Disease (ICVD) Dedinje

Belgrade, Serbia, Serbia

National University Hospital

Singapore, , Singapore

National Heart Centre Singapore

Singapore, , Singapore

National University Hospital

Singapore, , Singapore

Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

Banská Bystrica, , Slovakia

Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

Bratislava, , Slovakia

Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

Košice, , Slovakia

Netcare Sunninghill Hospital

Johannesburg, , South Africa

Busamed Gateway Hospital

Umhlanga, , South Africa

Seoul National University Bundang Hospital

Seoul, Gyeonggi-do, South Korea

Hallym University Sacred Heart Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Hospital Universitario Moncloa

Madrid, , Spain

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan, Taiwan

Cheng-Hsin General Hospital

Taipei, Taiwan, Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Siriraj Hospital

Bangkok, Thailand, 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, United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, , United Kingdom

St George's University Hospitals - NHS Trust

London, , United Kingdom

St. George's Hospital-NHS Trust

London, , United Kingdom

St. Bartholomew's Hospital

London, , United Kingdom

Countries

United States; Argentina; Austria; Belgium; Brunei; Chile; China; Colombia; Czechia; Germany; Greece; Hungary; Iceland; India; Indonesia; Italy; Japan; Kazakhstan; Kuwait; Malaysia; Mexico; Oman; Philippines; Poland; Portugal; Russia; Saudi Arabia; Serbia; Singapore; Slovakia; South Africa; South Korea; Spain; Switzerland; Taiwan; Thailand; United Arab Emirates; United Kingdom

References

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 Jun 20:S0972-6292(25)00090-7. doi: 10.1016/j.ipej.2025.06.008. Online ahead of print.

Reference Type: DERIVED

PMID: 40545038 (View on PubMed)

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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 39836630 (View on PubMed)

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.

Reference Type: DERIVED

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Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 37505337 (View on PubMed)

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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 36097833 (View on PubMed)

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Reference Type: DERIVED

PMID: 34889108 (View on PubMed)

Other Identifiers

Cryo Global Registry

Identifier Type: -

Identifier Source: org_study_id