Cryo Global Registry

July 29, 2025 updated by: Medtronic Cardiac Ablation Solutions

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

5385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Universitario Fundacion Favaloro
      • Buenos Aires, Argentina, C1428DCO
        • Instituto Cardiovascular de Buenos Aires (ICBA)
      • Buenos Aires, Argentina, CP:1428
        • Institituo Cardiovascular Buenos Aires (ICBA)
  • Austria
      • Linz, Austria, 4021
        • Kepler Universitätsklinikum Med Campus III.
  • Belgium
      • Aalst, Belgium
        • Onze-Lieve-Vrouwziekenhuis-Campus Aalst
    • Liege
      • Liège, Liege, Belgium, 4000
        • Centre Hospitalier Regional de la Citadelle
  • Brunei Darussalam
    • Brunei
      • Bandar Seri Begawan, Brunei, Brunei Darussalam, BG3122
        • Gleneagles Jerudong Park Medical Centre
  • Chile
      • Santiago, Chile
        • Clínica Dávila
  • China
      • Beijing, China, 100037
        • Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
      • Chengdu, China, 610041
        • West China Hospital of Sichuan University
      • Shanghai, China, 200072
        • Shanghai Tenth People's Hospital
      • Shanghai, China
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
      • Tianjin, China, 300051
        • Tianjin Chest Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
  • Colombia
      • Bogotá, Colombia
        • Fundación Clínica Shaio
      • Medellin, Colombia
        • Clinica Ces
  • Czechia
      • Prague, Czechia, 150 30
        • Nemocnice na Homolce
  • Germany
      • Bad Bevensen, Germany, 29549
        • Herz- und Gefasszentrum Bad Bevensen
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken GmbH - Herzzentrum
      • Berlin, Germany, 10365
        • Sana Klinikum Lichtenberg
      • Bielefeld, Germany, 33604
        • Städtische Kliniken Bielefeld
      • Coburg, Germany, 69450
        • Klinikum Coburg GmbH
      • Frankfurt, Germany, 60389
        • Cardioangiologisches Centrum Bethanien
      • Köln, Germany, 50733
        • St. Vinzenz-Hospital Köln
      • Lüdenscheid, Germany, 58515
        • Klinikum Lüdenscheid
      • Mönchengladbach, Germany, 41063
        • Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus
      • München, Germany
        • Städtische Kliniken München GmbH - Klinikum Bogenhausen
      • Ravensburg, Germany, 88212
        • Oberschwaben-Klinik GmbH - Krankenhaus St. Elisabeth
      • Wiesbaden, Germany, 65189
        • St. Josephs Hospital Wiesbaden
    • North Rhine-Westphalia
      • Lüdenscheid, North Rhine-Westphalia, Germany, 58515
        • Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid
  • Greece
      • Athens, Greece, 11525
        • Hellenic Airforce 251 General Hospital
  • Hungary
      • Budapest, Hungary
        • Gottsegen György Országos Kardiológiai Intézet
      • Debrecen, Hungary
        • Debreceni Egyetem
  • Iceland
      • Reykjavik, Iceland, 108
        • Landspitali - National Hospital of Iceland
  • India
      • Hyderabad, India
        • AIG hospital
      • New Delhi, India, 110017
        • Max Super Speciality Hospital
    • Kerala
      • Kochi, Kerala, India, 682027
        • Aster Medcity
      • Thiruvananthapuram, Kerala, India, 695011
        • Sree Chitra Tirunal Institute for Medical Sciences & Technology
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Eternal Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600006
        • Apollo Hospital (Chennai)
  • Indonesia
      • Jakarta, Indonesia, 11420
        • National Cardiovascular Center Harapan Kita
      • Jakarta, Indonesia
        • National Cardiovascular Center Harapan Kita
  • Italy
      • Castellanza, Italy, 21053
        • Humanitas Mater Domini
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San
      • Perugia, Italy, 06129
        • Ospedale S. Maria Della Misericordia
      • Pisa, Italy, 56100
        • Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
  • Japan
      • Amagasaki, Japan
        • Kansai Rosai Hospital
      • Amagasaki, Japan
        • Hyogo Prefectural Amagasaki General Medical Center
      • Anjō, Japan
        • Anjo Kosei Hospital
      • Bunkyō-Ku, Japan
        • Nippon Medical School Hospital
      • Bunkyō-Ku, Japan, 113-8519
        • Tokyo Medical And Dental University, Medical Hospital
      • Chiba, Japan
        • Chiba University Hospital
      • Fukuoka, Japan, 814-0001
        • Fukuoka Sanno Hospital
      • Hachiōji, Japan
        • Tokai University Hachioji Hospital
      • Hidaka, Japan
        • Saitama Medical University International Medical Center
      • Hirosaki, Japan, 036-8563
        • Hirosaki University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hospital
      • Hiroshima, Japan
        • Hiroshima City Hospital
      • Ishikawa, Japan
        • Kanazawa University Hospital
      • Itabashi-ku, Japan
        • Nihon University Itabashi Hospital
      • Kagoshima, Japan
        • National Hospital Organization Kagoshima MC
      • Kitakyushu, Japan, 802-8555
        • Kokura Kinen Hospital
      • Kobe, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Koshigaya, Japan
        • Dokkyo Medical University Saitama Medical Center
      • Kumamoto, Japan
        • Saiseikai Kumamoto Hospital
      • Kyoto, Japan, 606-8507
        • Kyoto University hospital
      • Minato-Ku, Japan
        • The Jikei University School of Medicine Hospital
      • Mitaka, Japan
        • Kyorin University Hospital
      • Miwa, Japan
        • Mie Heart Center
      • Miyazaki, Japan, 880-0834
        • Miyazaki Medical Association Hospital
      • Nagoya, Japan
        • Nagoya City University East Medical Center
      • Nankoku, Japan
        • Kochi Medical School Hospital
      • Okayama, Japan
        • Kurashiki Central Hospital
      • Osaka, Japan, 530-0001
        • Sakurabashi Watanabe Hospital
      • Sagamihara, Japan
        • Kitasato University Hospital
      • Saitama, Japan, 330-8553
        • Japanese Red Cross Saitama Hospital
      • Sendai, Japan
        • Sendai City Hospital
      • Shimotsuke-shi, Japan
        • Jichi Medical University Hospital
      • Suita, Japan
        • National cerebral and cardiovascular center
      • Tenri, Japan
        • Tenri Hospital
      • Tokyo, Japan
        • Tokyo Metropolitan Hiroo Hospital
      • Tokyo, Japan, 135-8577
        • Showa University Toyosu Hospital
      • Tokyo, Japan
        • Tokyo Medical Center
      • Toyama, Japan
        • Toyama Prefectural Central Hospital
      • Toyoake, Japan
        • Fujita Health University Hospital
      • Tsukuba, Japan
        • University of Tsukuba Hospital
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
      • Yokkaichi, Japan
        • Yokkaichi Municipal Hospital
      • Yokohama, Japan, 231-8682
        • Yokohama City Minato Red Cross Hospital
      • Yoshida, Japan
        • University of Fukui Hospital
      • Ōsaka-sayama, Japan, 589-8511
        • Kindai University Hospital
      • Ōta, Japan
        • Toho University Omori Medical Center
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Nagoya University Hospital
      • Nagoya, Aichi, Japan, 466-8650
        • Japanese Red Cross Nagoya Daini Hospital
    • Gifu
      • Ogaki City, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital
    • Hiroshima
      • Hiroshima City, Hiroshima, Japan, 734-8530
        • Hiroshima Prefectural Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 063-0052
        • Hokkaido Ohno Memorial Hospital
      • Sapporo, Hokkaido, Japan, 065-0027
        • Caress Sapporo Hokko Memorial Hospital
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan, 300-0028
        • Tsuchiura Kyodo General Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Kamakura, Kanagawa, Japan, 247-8533
        • Shonan Kamakura General Hospital
    • Kansai
      • Wakayama, Kansai, Japan, 640-8558
        • Japanese Red Cross Wakayama Medical Center
    • Osaka
      • Sakai, Osaka, Japan, 591-8025
        • Osaka Rosai Hospital
      • Sumiyoshi-ku, Osaka, Japan, 558-8558
        • Osaka General Medical Center
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8655
        • Tokyo University Hospital
      • Fuchu, Tokyo, Japan, 183-0003
        • Sakakibara Heart Institute
  • Kazakhstan
      • Astana, Kazakhstan
        • National Research Cardiac Surgery Center
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 152-703
        • Hallym University Sacred Heart Hospital
    • Gyeonggi-do
      • Seoul, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
  • Kuwait
      • Al-Ahmadi, Kuwait
        • Salman Al Abdallah Al Dabbous Cardiac Center (DCC) - Al Adan Hospital
      • Kuwait, Kuwait
        • Chest Diseases Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara
      • Kuala Lumpur, Malaysia, 50470
        • Cardiac Vascular Sentral Kuala Lumpur (CVSKL)
    • Sarawak
      • Kuching, Sarawak, Malaysia, 94300
        • Sarawak Heart Centre
    • Selangor
      • Sepang, Selangor, Malaysia, 43000
        • Hospital Serdang
  • Mexico
      • Huixquilucan, Mexico, 52763
        • Hospital Angeles Lomas
      • Mexico, Mexico, 03330
        • Hospital San Angel Inn Universidad
      • Mexico City, Mexico, 06720
        • Centro Médico Nacional Siglo XXI
  • Oman
      • Muscat, Oman
        • The Royal Hospital
  • Philippines
    • Metro Manila
      • Pasig, Metro Manila, Philippines, 1603
        • The Medical City
      • Taguig, Metro Manila, Philippines, 1634
        • Saint Lukes Medical Center (SLMC)
  • Poland
      • Kraków, Poland
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II
      • Rzeszow, Poland, 35-301
        • Spital Wojewodzki nr 2
      • Rzeszów, Poland
        • Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie
      • Łódź, Poland
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
  • Portugal
      • Vila Nova De Gaia, Portugal, 4434-502
        • Centro hospitalar Vila Nova de Gaia/Espinho-Unidade I
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
        • State Budgetary Healthcare Institution of Sverdlovsk region for "Sverdlovsk Regional Clinical Hospital #1"
      • Moscow, Russian Federation
        • Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
      • Tomsk, Russian Federation
        • Tomsk National Research Medical Center of the Russian Academy of Sciences
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11433
        • King Fahad Medical City (KFMC)
  • Serbia
      • Belgrade, Serbia, 11040
        • Institute for Cardiovascular Disease (ICVD) Dedinje
  • Singapore
      • Singapore, Singapore
        • National University Hospital
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 169609
        • National Heart Centre Singapore
  • Slovakia
      • Banská Bystrica, Slovakia, 97401
        • Stredoslovensky ustav srdcovych a cievnych chorob a.s
      • Bratislava, Slovakia, 83348
        • Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
      • Košice, Slovakia, 04011
        • Východoslovenský Ústav Srdcových A Cievnych Chorôb, A.S.
  • South Africa
      • Johannesburg, South Africa
        • Netcare Sunninghill Hospital
      • Umhlanga, South Africa, 4319
        • Busamed Gateway Hospital
  • Spain
      • Madrid, Spain, 28008
        • Hospital Universitario Moncloa
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei City, Taiwan
        • Taipei Veterans General Hospital
      • Taipei City, Taiwan, 10491
        • Mackay Memorial Hospital
      • Taipei City, Taiwan, 112
        • Cheng-Hsin General Hospital
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand
        • Ramathibodi Hospital
      • Bangkok, Thailand
        • Phramongkutklao Hospital
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Cleveland Clinic Abu Dhabi
      • Abu Dhabi, United Arab Emirates
        • Sheikh Khalifa Medical City
  • United Kingdom
      • Liverpool, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • London, United Kingdom
        • St. Bartholomew's Hospital
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals - NHS Trust
      • London, United Kingdom, SW17 0QT
        • St. George's Hospital-NHS Trust
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503-2560
        • Spectrum Health Hospitals
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Research Center
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Health Cardiology
    • Texas
      • Austin, Texas, United States, 78705-1852
        • Texas Cardiac Arrhythmia Research Foundation
      • Dallas, Texas, United States, 75231
        • Texas Health Research & Education Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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
  • Subject with exclusion criteria required by local law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Months
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.
12 Months
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.
12 Months
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Ablation Solutions

Investigators

  • Study Director: Khaldoun Tarakji, MD, Medtronic CAS Chief Medical Officer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2016

Primary Completion (Actual)

November 29, 2024

Study Completion (Actual)

November 29, 2024

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimated)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cryo Global Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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