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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02752737
Other study ID # Cryo Global Registry
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 2016
Est. completion date January 2028

Study information

Verified date April 2024
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5000
Est. completion date January 2028
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Hospital Universitario Fundación Favaloro Buenos Aires
Argentina Institituo Cardiovascular Buenos Aires (ICBA) Buenos Aires
Argentina Instituto Cardiovascular de Buenos Aires (ICBA) Buenos Aires
Austria Kepler Universitätsklinikum Med Campus III. Linz
Belgium Onze-Lieve-Vrouwziekenhuis-Campus Aalst Aalst
Belgium Centre Hospitalier Régional de la Citadelle Liège Liege
Brunei Darussalam Gleneagles Jerudong Park Medical Centre Bandar Seri Begawan
Chile Clínica Dávila Santiago
China Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing
China West China Hospital of Sichuan University Chengdu
China Ruijin Hospital Shanghai Jiao Tong University School of Medicine Shanghai
China Shanghai Tenth People's Hospital Shanghai
China Tianjin Chest Hospital Tianjin
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Colombia Fundacion Clinica Shaio Bogotá
Colombia Clinica Ces Medellin
Czechia Nemocnice Na Homolce Prague
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 Cardioangiologisches Centrum Bethanien Frankfurt
Germany St. Vinzenz-Hospital Köln Köln
Germany Klinikum Lüdenscheid Lüdenscheid
Germany Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid Lüdenscheid North Rhine-Westphalia
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
Greece Hellenic Airforce 251 General Hospital Athens
Hungary Gottsegen György Országos Kardiológiai Intézet Budapest
Hungary Debreceni Egyetem Debrecen
Iceland Landspitali - National Hospital of Iceland Reykjavik
India Apollo Hospital (Chennai) Chennai Tamil Nadu
India Aig Hospital Hyderabad
India Eternal Hospital Jaipur Rajasthan
India Aster Medcity Kochi Kerala
India Max Super Speciality Hospital New Delhi
India Sree Chitra Tirunal Institute for Medical Sciences & Technology Thiruvananthapuram Kerala
Indonesia National Cardiovascular Center Harapan Kita Jakarta
Indonesia National Cardiovascular Center Harapan Kita Jakarta
Italy 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
Japan Hyogo Prefectural Amagasaki General Medical Center Amagasaki
Japan Kansai Rosai Hospital Amagasaki
Japan Anjo Kosei Hospital Anjo
Japan Nippon Medical School Hospital Bunkyo-Ku
Japan Tokyo Medical and Dental University, Medical Hospital Bunkyo-Ku
Japan Tokyo University Hospital Bunkyo-Ku Tokyo
Japan Chiba University Hospital Chiba
Japan Sakakibara Heart Institute Fuchu Tokyo
Japan Fukuoka Sanno Hospital Fukuoka
Japan Tokai University Hachioji Hospital Hachioji
Japan Saitama Medical University International Medical Center Hidaka
Japan Hirosaki University Hospital Hirosaki
Japan Hiroshima City Hospital Hiroshima
Japan Hiroshima City Hospital Hiroshima
Japan Hiroshima University Hospital Hiroshima
Japan Hiroshima Prefectural Hospital Hiroshima City Hiroshima
Japan Tokai University Hospital Isehara Kanagawa
Japan Kanazawa University Hospital Ishikawa
Japan Nihon University Itabashi Hospital Itabashi-ku
Japan National Hospital Organization Kagoshima MC Kagoshima
Japan Shonan Kamakura General Hospital Kamakura Kanagawa
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 Minato-Ku
Japan Kyorin University Hospital Mitaka
Japan Mie Heart Center Miwa
Japan Miyazaki Medical Association Hospital Miyazaki
Japan Japanese Red Cross Nagoya Daini Hospital Nagoya Aichi
Japan Nagoya City University East Medical Center Nagoya
Japan Nagoya University Hospital Nagoya Aichi
Japan Kochi Medical School Hospital Nankoku
Japan Ogaki Municipal Hospital Ogaki City Gifu
Japan Kurashiki Central Hospital Okayama
Japan Sakurabashi Watanabe Hospital Osaka
Japan Kindai University Hospital Osaka-sayama
Japan Toho University Omori Medical Center Ota
Japan Kitasato University Hospital Sagamihara
Japan Japanese Red Cross Saitama Hospital Saitama
Japan Osaka Rosai Hospital Sakai Osaka
Japan Caress Sapporo Hokko Memorial Hospital Sapporo Hokkaido
Japan Hokkaido Ohno Memorial Hospital Sapporo Hokkaido
Japan Sendai City Hospital Sendai
Japan Jichi Medical University Hospital Shimotsuke-shi
Japan National Cerebral and Cardiovascular Center Suita
Japan Osaka General Medical Center Sumiyoshi-ku Osaka
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 Tsuchiura Kyodo General Hospital Tsuchiura Ibaraki
Japan University of Tsukuba Hospital Tsukuba
Japan Japanese Red Cross Wakayama Medical Center Wakayama Kansai
Japan Yamagata University Hospital Yamagata
Japan Yokkaichi Municipal Hospital Yokkaichi
Japan Yokohama City Minato Red Cross Hospital Yokohama
Japan University of Fukui Hospital Yoshida
Kazakhstan National Research Cardiac Surgery Center Astana
Korea, Republic of Hallym University Sacred Heart Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Bundang Hospital Seoul Gyeonggi-do
Kuwait Salman Al Abdallah Al Dabbous Cardiac Center (DCC) - Al Adan Hospital Al-Ahmadi
Kuwait Chest Diseases Hospital Kuwait
Malaysia Cardiac Vascular Sentral Kuala Lumpur (CVSKL) Kuala Lumpur
Malaysia Institut Jantung Negara Kuala Lumpur
Malaysia Sarawak Heart Centre Kuching Sarawak
Malaysia Hospital Serdang Sepang Selangor
Mexico Hospital Angeles Lomas Huixquilucan
Mexico Hospital San Angel Inn Universidad Mexico
Mexico Centro Médico Nacional Siglo XXI Mexico City
Oman The Royal Hospital Muscat
Philippines The Medical City Pasig Metro Manila
Philippines Saint Lukes Medical Center (SLMC) Taguig Metro Manila
Poland Krakowski Szpital Specjalistyczny im. Jana Pawla II Kraków
Poland Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Lódz
Poland Spital Wojewodzki nr 2 Rzeszow
Poland Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie Rzeszów
Portugal Centro hospitalar Vila Nova de Gaia/Espinho-Unidade I Vila Nova De Gaia
Russian Federation State Budgetary Healthcare Institution of Sverdlovsk region for "Sverdlovsk Regional Clinical Hospital #1" Ekaterinburg
Russian Federation Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN Moscow
Russian Federation Tomsk National Research Medical Center of the Russian Academy of Sciences Tomsk
Saudi Arabia King Fahad Medical City (KFMC) Riyadh
Serbia Institute for Cardiovascular Disease (ICVD) Dedinje Belgrade
Singapore National Heart Centre Singapore Singapore
Singapore National University Hospital Singapore
Singapore National University Hospital Singapore
Slovakia 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
South Africa Netcare Sunninghill Hospital Johannesburg
South Africa Busamed Gateway Hospital Umhlanga
Spain Hospital Universitario Moncloa Madrid
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Cheng-Hsin General Hospital Taipei City
Taiwan Mackay Memorial Hospital Taipei City
Taiwan Taipei Veterans General Hospital Taipei City
Thailand Phramongkutklao Hospital Bangkok
Thailand Ramathibodi Hospital Bangkok
Thailand Siriraj Hospital Bangkok
United Arab Emirates Cleveland Clinic Abu Dhabi Abu Dhabi
United Arab Emirates Sheikh Khalifa Medical City Abu Dhabi
United Kingdom Liverpool Heart and Chest Hospital NHS Foundation Trust Liverpool
United Kingdom St George's University Hospitals - NHS Trust London
United Kingdom St. Bartholomew's Hospital London
United Kingdom St. George's Hospital-NHS Trust London
United Kingdom The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital Newcastle Upon Tyne
United States Texas Cardiac Arrhythmia Research Foundation Austin Texas
United States The Lindner Research Center Cincinnati Ohio
United States Texas Health Research & Education Institute Dallas Texas
United States Doylestown Health Cardiology Doylestown Pennsylvania
United States Spectrum Health Hospitals Grand Rapids Michigan
United States Carle Foundation Hospital Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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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