Clinical trial NCT02752737: Cryo Global Registry
Official title: Cryo Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2016-04-27
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years or older with a planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter.

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.

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
* Subject with exclusion criteria required by local law

Primary outcomes:
measure: Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months
timeFrame: 12 Months
measure: Freedom from Atrial Arrhythmia at 12 Months
timeFrame: 12 Months
measure: Freedom from Arrythmias at 12 months
timeFrame: 12 Months
measure: Freedom from Device / Procedure Related Adverse Events
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Health Cardiology
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Texas Health Research & Education Institute
state: Texas
city: Buenos Aires
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires (ICBA)
city: Buenos Aires
country: Argentina
facility: Institituo Cardiovascular Buenos Aires (ICBA)
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Fundación Favaloro
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Med Campus III.
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
state: Liege
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis-Campus Aalst
city: Bandar Seri Begawan
country: Brunei Darussalam
facility: Gleneagles Jerudong Park Medical Centre
state: Brunei
city: Santiago
country: Chile
facility: Clínica Dávila
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
city: Tianjin
country: China
facility: Tianjin Chest Hospital
city: Bogotá
country: Colombia
facility: Fundacion Clinica Shaio
city: Medellin
country: Colombia
facility: Clinica Ces
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Lüdenscheid
country: Germany
facility: Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid
state: North Rhine-Westphalia
city: Bad Bevensen
country: Germany
facility: Herz- und Gefässzentrum Bad Bevensen
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH - Herzzentrum
city: Berlin
country: Germany
facility: Sana Klinikum Lichtenberg
city: Bielefeld
country: Germany
facility: Städtische Kliniken Bielefeld
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Köln
country: Germany
facility: St. Vinzenz-Hospital Köln
city: Lüdenscheid
country: Germany
facility: Klinikum Lüdenscheid
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus
city: München
country: Germany
facility: Städtische Kliniken München GmbH - Klinikum Bogenhausen
city: Ravensburg
country: Germany
facility: Oberschwaben-Klinik GmbH - Krankenhaus St. Elisabeth
city: Wiesbaden
country: Germany
facility: St. Josephs Hospital Wiesbaden
city: Athens
country: Greece
facility: Hellenic Airforce 251 General Hospital
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiológiai Intézet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Reykjavik
country: Iceland
facility: Landspitali - National Hospital of Iceland
city: Kochi
country: India
facility: Aster Medcity
state: Kerala
city: Thiruvananthapuram
country: India
facility: Sree Chitra Tirunal Institute for Medical Sciences & Technology
state: Kerala
city: Jaipur
country: India
facility: Eternal Hospital
state: Rajasthan
city: Chennai
country: India
facility: Apollo Hospital (Chennai)
state: Tamil Nadu
city: Hyderabad
country: India
facility: Aig Hospital
city: New Delhi
country: India
facility: Max Super Speciality Hospital
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
city: Castellanza
country: Italy
facility: Humanitas Mater Domini
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
state: Aichi
city: Ogaki City
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Hiroshima City
country: Japan
facility: Hiroshima Prefectural Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: Hokkaido Ohno Memorial Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Caress Sapporo Hokko Memorial Hospital
state: Hokkaido
city: Tsuchiura
country: Japan
facility: Tsuchiura Kyodo General Hospital
state: Ibaraki
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Wakayama
country: Japan
facility: Japanese Red Cross Wakayama Medical Center
state: Kansai
city: Sakai
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
city: Sumiyoshi-ku
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Bunkyo-Ku
country: Japan
facility: Tokyo University Hospital
state: Tokyo
city: Fuchu
country: Japan
facility: Sakakibara Heart Institute
state: Tokyo
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
city: Anjō
country: Japan
facility: Anjo Kosei Hospital
city: Bunkyō-Ku
country: Japan
facility: Tokyo Medical and Dental University, Medical Hospital
city: Bunkyō-Ku
country: Japan
facility: Nippon Medical School Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: Fukuoka Sanno Hospital
city: Hachiōji
country: Japan
facility: Tokai University Hachioji Hospital
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
city: Kagoshima
country: Japan
facility: National Hospital Organization Kagoshima MC
city: Kitakyushu
country: Japan
facility: Kokura Kinen Hospital
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Minato-Ku
country: Japan
facility: The Jikei University School of Medicine Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Miwa
country: Japan
facility: Mie Heart Center
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Nagoya
country: Japan
facility: Nagoya City University East Medical Center
city: Nankoku
country: Japan
facility: Kochi Medical School Hospital
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Saitama
country: Japan
facility: Japanese Red Cross Saitama Hospital
city: Sendai
country: Japan
facility: Sendai City Hospital
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Tenri
country: Japan
facility: Tenri Hospital
city: Tokyo
country: Japan
facility: Showa University Toyosu Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical Center
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Hiroo Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Yokkaichi
country: Japan
facility: Yokkaichi Municipal Hospital
city: Yokohama
country: Japan
facility: Yokohama City Minato Red Cross Hospital
city: Yoshida
country: Japan
facility: University of Fukui Hospital
city: Ōsaka-sayama
country: Japan
facility: Kindai University Hospital
city: Ōta
country: Japan
facility: Toho University Omori Medical Center
city: Astana
country: Kazakhstan
facility: National Research Cardiac Surgery Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Al-Ahmadi
country: Kuwait
facility: Salman Al Abdallah Al Dabbous Cardiac Center (DCC) - Al Adan Hospital
city: Kuwait
country: Kuwait
facility: Chest Diseases Hospital
city: Kuching
country: Malaysia
facility: Sarawak Heart Centre
state: Sarawak
city: Sepang
country: Malaysia
facility: Hospital Serdang
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Kuala Lumpur
country: Malaysia
facility: Cardiac Vascular Sentral Kuala Lumpur (CVSKL)
city: Huixquilucan
country: Mexico
facility: Hospital Angeles Lomas
city: Mexico City
country: Mexico
facility: Centro Médico Nacional Siglo XXI
city: Mexico
country: Mexico
facility: Hospital San Angel Inn Universidad
city: Muscat
country: Oman
facility: The Royal Hospital
city: Pasig
country: Philippines
facility: The Medical City
state: Metro Manila
city: Taguig
country: Philippines
facility: Saint Lukes Medical Center (SLMC)
state: Metro Manila
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Rzeszow
country: Poland
facility: Spital Wojewodzki nr 2
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie
city: Łódź
country: Poland
facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
city: Vila Nova De Gaia
country: Portugal
facility: Centro hospitalar Vila Nova de Gaia/Espinho-Unidade I
city: Ekaterinburg
country: Russian Federation
facility: State Budgetary Healthcare Institution of Sverdlovsk region for "Sverdlovsk Regional Clinical Hospital #1"
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Center of the Russian Academy of Sciences
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City (KFMC)
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular Disease (ICVD) Dedinje
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: National University Hospital
city: Banská Bystrica
country: Slovakia
facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
city: Bratislava
country: Slovakia
facility: Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
city: Košice
country: Slovakia
facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
city: Johannesburg
country: South Africa
facility: Netcare Sunninghill Hospital
city: Umhlanga
country: South Africa
facility: Busamed Gateway Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Moncloa
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei City
country: Taiwan
facility: Cheng-Hsin General Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Khalifa Medical City
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospitals - NHS Trust
city: London
country: United Kingdom
facility: St. George's Hospital-NHS Trust
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Study officials:
affiliation: Medtronic CAS Chief Medical Officer
name: Khaldoun Tarakji, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.