Cryo Global Registry
Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02752737
Collaborator
(none)
5,000
158
103
31.6
0.3
Study Details
Study Description
Brief Summary
Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cryo Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
Study Start Date
:
May 1, 2016
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2024
Outcome Measures
Primary Outcome Measures
- Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months [12 Months]
Estimate the 12 month freedom from AF recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System
- Freedom from Atrial Arrhythmia at 12 Months [12 Months]
Estimate the 12 month freedom from AF / Atrial Flutter (AFL)/ Atrial Tachycardia (AT) using the Arctic Front™ Cardiac Cryoablation Catheter System.
- Freedom from Device / Procedure Related Adverse Events [12 Months]
Estimate device and procedure-related adverse events for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12 months.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 2 | Spectrum Health Hospitals | Grand Rapids | Michigan | United States | 49503-2560 |
| 3 | The Lindner Research Center | Cincinnati | Ohio | United States | 45219 |
| 4 | Doylestown Health Cardiology | Doylestown | Pennsylvania | United States | 18901 |
| 5 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705-1852 |
| 6 | Texas Health Research & Education Institute | Dallas | Texas | United States | 75231 |
| 7 | Instituto Cardiovascular de Buenos Aires (ICBA) | Buenos Aires | Argentina | C1428DCO | |
| 8 | Institituo Cardiovascular Buenos Aires (ICBA) | Buenos Aires | Argentina | CP:1428 | |
| 9 | Hospital Universitario Fundación Favaloro | Buenos Aires | Argentina | ||
| 10 | Kepler Universitätsklinikum Med Campus III. | Linz | Austria | 4021 | |
| 11 | Centre Hospitalier Régional de la Citadelle | Liège | Liege | Belgium | 4000 |
| 12 | Onze-Lieve-Vrouwziekenhuis-Campus Aalst | Aalst | Belgium | ||
| 13 | Gleneagles Jerudong Park Medical Centre | Bandar Seri Begawan | Brunei Darussalam | BG3122 | |
| 14 | Clínica Dávila | Santiago | Chile | ||
| 15 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | 450052 |
| 16 | Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | China | 100037 | |
| 17 | West China Hospital of Sichuan University | Chengdu | China | 610041 | |
| 18 | Shanghai Tenth People's Hospital | Shanghai | China | 200072 | |
| 19 | Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | China | ||
| 20 | Tianjin Chest Hospital | Tianjin | China | 300051 | |
| 21 | Fundacion Clinica Shaio | Bogotá | Colombia | ||
| 22 | Clinica Ces | Medellin | Colombia | ||
| 23 | Nemocnice Na Homolce | Prague | Czechia | 150 30 | |
| 24 | Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid | Lüdenscheid | North Rhine-Westphalia | Germany | 58515 |
| 25 | Herz- und Gefässzentrum Bad Bevensen | Bad Bevensen | Germany | 29549 | |
| 26 | Segeberger Kliniken GmbH - Herzzentrum | Bad Segeberg | Germany | 23795 | |
| 27 | Sana Klinikum Lichtenberg | Berlin | Germany | 10365 | |
| 28 | Städtische Kliniken Bielefeld | Bielefeld | Germany | 33604 | |
| 29 | Klinikum Coburg GmbH | Coburg | Germany | 69450 | |
| 30 | Cardioangiologisches Centrum Bethanien | Frankfurt | Germany | 60389 | |
| 31 | St. Vinzenz-Hospital Köln | Köln | Germany | 50733 | |
| 32 | Klinikum Lüdenscheid | Lüdenscheid | Germany | 58515 | |
| 33 | Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus | Mönchengladbach | Germany | 41063 | |
| 34 | Städtische Kliniken München GmbH - Klinikum Bogenhausen | München | Germany | ||
| 35 | Oberschwaben-Klinik GmbH - Krankenhaus St. Elisabeth | Ravensburg | Germany | 88212 | |
| 36 | St. Josephs Hospital Wiesbaden | Wiesbaden | Germany | 65189 | |
| 37 | Hellenic Airforce 251 General Hospital | Athens | Greece | 11525 | |
| 38 | Gottsegen György Országos Kardiológiai Intézet | Budapest | Hungary | ||
| 39 | Debreceni Egyetem | Debrecen | Hungary | ||
| 40 | Landspitali - National Hospital of Iceland | Reykjavik | Iceland | 108 | |
| 41 | Aig Hospital | Hyderabad | India | ||
| 42 | National Cardiovascular Center Harapan Kita | Jakarta | Indonesia | 11420 | |
| 43 | National Cardiovascular Center Harapan Kita | Jakarta | Indonesia | ||
| 44 | Humanitas Mater Domini | Castellanza | Italy | 21053 | |
| 45 | Fondazione IRCCS Policlinico San | Pavia | Italy | ||
| 46 | Ospedale S. Maria della Misericordia | Perugia | Italy | 06129 | |
| 47 | Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello | Pisa | Italy | 56100 | |
| 48 | Nagoya University Hospital | Nagoya | Aichi | Japan | 466-8560 |
| 49 | Japanese Red Cross Nagoya Daini Hospital | Nagoya | Aichi | Japan | 466-8650 |
| 50 | Ogaki Municipal Hospital | Ogaki City | Gifu | Japan | 503-8502 |
| 51 | Hiroshima Prefectural Hospital | Hiroshima City | Hiroshima | Japan | 734-8530 |
| 52 | Hokkaido Ohno Memorial Hospital | Sapporo | Hokkaido | Japan | 063-0052 |
| 53 | Caress Sapporo Hokko Memorial Hospital | Sapporo | Hokkaido | Japan | 065-0027 |
| 54 | Tsuchiura Kyodo General Hospital | Tsuchiura | Ibaraki | Japan | 300-0028 |
| 55 | Tokai University Hospital | Isehara | Kanagawa | Japan | 259-1193 |
| 56 | Shonan Kamakura General Hospital | Kamakura | Kanagawa | Japan | 247-8533 |
| 57 | Japanese Red Cross Wakayama Medical Center | Wakayama | Kansai | Japan | 640-8558 |
| 58 | Osaka Rosai Hospital | Sakai | Osaka | Japan | 591-8025 |
| 59 | Osaka General Medical Center | Sumiyoshi-ku | Osaka | Japan | 558-8558 |
| 60 | Tokyo University Hospital | Bunkyo-Ku | Tokyo | Japan | 113-8655 |
| 61 | Sakakibara Heart Institute | Fuchu | Tokyo | Japan | 183-0003 |
| 62 | Hyogo Prefectural Amagasaki General Medical Center | Amagasaki | Japan | ||
| 63 | Kansai Rosai Hospital | Amagasaki | Japan | ||
| 64 | Anjo Kosei Hospital | Anjō | Japan | ||
| 65 | Tokyo Medical and Dental University, Medical Hospital | Bunkyō-Ku | Japan | 113-8519 | |
| 66 | Nippon Medical School Hospital | Bunkyō-Ku | Japan | ||
| 67 | Chiba University Hospital | Chiba | Japan | ||
| 68 | Fukuoka Sanno Hospital | Fukuoka | Japan | 814-0001 | |
| 69 | Tokai University Hachioji Hospital | Hachiōji | Japan | ||
| 70 | Saitama Medical University International Medical Center | Hidaka | Japan | ||
| 71 | Hirosaki University Hospital | Hirosaki | Japan | 036-8563 | |
| 72 | Hiroshima City Hospital | Hiroshima | Japan | 730-8518 | |
| 73 | Hiroshima University Hospital | Hiroshima | Japan | 734-8551 | |
| 74 | Hiroshima City Hospital | Hiroshima | Japan | ||
| 75 | Kanazawa University Hospital | Ishikawa | Japan | ||
| 76 | Nihon University Itabashi Hospital | Itabashi-ku | Japan | ||
| 77 | National Hospital Organization Kagoshima MC | Kagoshima | Japan | ||
| 78 | Kokura Kinen Hospital | Kitakyushu | Japan | 802-8555 | |
| 79 | Kobe City Medical Center General Hospital | Kobe | Japan | 650-0047 | |
| 80 | Dokkyo Medical University Saitama Medical Center | Koshigaya | Japan | ||
| 81 | Saiseikai Kumamoto Hospital | Kumamoto | Japan | ||
| 82 | Kyoto University Hospital | Kyoto | Japan | 606-8507 | |
| 83 | The Jikei University School of Medicine Hospital | Minato-Ku | Japan | ||
| 84 | Kyorin University Hospital | Mitaka | Japan | ||
| 85 | Mie Heart Center | Miwa | Japan | ||
| 86 | Miyazaki Medical Association Hospital | Miyazaki | Japan | 880-0834 | |
| 87 | Nagoya City University East Medical Center | Nagoya | Japan | ||
| 88 | Kochi Medical School Hospital | Nankoku | Japan | ||
| 89 | Kurashiki Central Hospital | Okayama | Japan | ||
| 90 | Sakurabashi Watanabe Hospital | Osaka | Japan | 530-0001 | |
| 91 | Kitasato University Hospital | Sagamihara | Japan | ||
| 92 | Japanese Red Cross Saitama Hospital | Saitama | Japan | 330-8553 | |
| 93 | Sendai City Hospital | Sendai | Japan | ||
| 94 | Jichi Medical University Hospital | Shimotsuke-shi | Japan | ||
| 95 | National Cerebral and Cardiovascular Center | Suita | Japan | ||
| 96 | Tenri Hospital | Tenri | Japan | ||
| 97 | Showa University Toyosu Hospital | Tokyo | Japan | 135-8577 | |
| 98 | Tokyo Medical Center | Tokyo | Japan | ||
| 99 | Tokyo Metropolitan Hiroo Hospital | Tokyo | Japan | ||
| 100 | Toyama Prefectural Central Hospital | Toyama | Japan | ||
| 101 | Fujita Health University Hospital | Toyoake | Japan | ||
| 102 | University of Tsukuba Hospital | Tsukuba | Japan | ||
| 103 | Yamagata University Hospital | Yamagata | Japan | 990-9585 | |
| 104 | Yokkaichi Municipal Hospital | Yokkaichi | Japan | ||
| 105 | Yokohama City Minato Red Cross Hospital | Yokohama | Japan | 231-8682 | |
| 106 | University of Fukui Hospital | Yoshida | Japan | ||
| 107 | Kindai University Hospital | Ōsaka-sayama | Japan | 589-8511 | |
| 108 | Toho University Omori Medical Center | Ōta | Japan | ||
| 109 | National Research Cardiac Surgery Center | Astana | Kazakhstan | ||
| 110 | Seoul National University Bundang Hospital | Seoul | Gyeonggi-do | Korea, Republic of | 463-707 |
| 111 | Hallym University Sacred Heart Hospital | Seoul | Korea, Republic of | 152-703 | |
| 112 | Samsung Medical Center | Seoul | Korea, Republic of | ||
| 113 | Salman Al Abdallah Al Dabbous Cardiac Center (DCC) - Al Adan Hospital | Al-Ahmadi | Kuwait | ||
| 114 | Chest Diseases Hospital | Kuwait | Kuwait | ||
| 115 | Sarawak Heart Centre | Kuching | Sarawak | Malaysia | 94300 |
| 116 | Hospital Serdang | Sepang | Selangor | Malaysia | 43000 |
| 117 | Institut Jantung Negara | Kuala Lumpur | Malaysia | 50400 | |
| 118 | Cardiac Vascular Sentral Kuala Lumpur (CVSKL) | Kuala Lumpur | Malaysia | 50470 | |
| 119 | Hospital Angeles Lomas | Huixquilucan | Mexico | 52763 | |
| 120 | Centro Médico Nacional Siglo XXI | Mexico City | Mexico | 06720 | |
| 121 | Hospital San Angel Inn Universidad | Mexico | Mexico | 03330 | |
| 122 | The Royal Hospital | Muscat | Oman | ||
| 123 | The Medical City | Pasig | Metro Manila | Philippines | 1603 |
| 124 | Saint Lukes Medical Center (SLMC) | Taguig | Metro Manila | Philippines | 1634 |
| 125 | Krakowski Szpital Specjalistyczny im. Jana Pawla II | Kraków | Poland | ||
| 126 | Spital Wojewodzki nr 2 | Rzeszow | Poland | 35-301 | |
| 127 | Kliniczny Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie | Rzeszów | Poland | ||
| 128 | Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi | Łódź | Poland | ||
| 129 | Centro hospitalar Vila Nova de Gaia/Espinho-Unidade I | Vila Nova De Gaia | Portugal | 4434-502 | |
| 130 | State Budgetary Healthcare Institution of Sverdlovsk region for "Sverdlovsk Regional Clinical Hospital #1" | Ekaterinburg | Russian Federation | 620102 | |
| 131 | Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN | Moscow | Russian Federation | ||
| 132 | Tomsk National Research Medical Center of the Russian Academy of Sciences | Tomsk | Russian Federation | ||
| 133 | King Fahad Medical City (KFMC) | Riyadh | Saudi Arabia | 11433 | |
| 134 | Institute for Cardiovascular Disease (ICVD) Dedinje | Belgrade | Serbia | 11040 | |
| 135 | National University Hospital | Singapore | Singapore | 119074 | |
| 136 | National Heart Centre Singapore | Singapore | Singapore | 169609 | |
| 137 | National University Hospital | Singapore | Singapore | ||
| 138 | Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s | Banská Bystrica | Slovakia | 97401 | |
| 139 | Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH) | Bratislava | Slovakia | 83348 | |
| 140 | Vychodoslovensky ustav srdcovych a cievnych chorob, a.s. | Košice | Slovakia | 04011 | |
| 141 | Netcare Sunninghill Hospital | Johannesburg | South Africa | ||
| 142 | Busamed Gateway Hospital | Umhlanga | South Africa | 4319 | |
| 143 | Hospital Universitario Moncloa | Madrid | Spain | 28008 | |
| 144 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | ||
| 145 | Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | |
| 146 | Mackay Memorial Hospital | Taipei City | Taiwan | 10491 | |
| 147 | Cheng-Hsin General Hospital | Taipei City | Taiwan | 112 | |
| 148 | Taipei Veterans General Hospital | Taipei City | Taiwan | ||
| 149 | Siriraj Hospital | Bangkok | Thailand | 10700 | |
| 150 | Phramongkutklao Hospital | Bangkok | Thailand | ||
| 151 | Ramathibodi Hospital | Bangkok | Thailand | ||
| 152 | Cleveland Clinic Abu Dhabi | Abu Dhabi | United Arab Emirates | ||
| 153 | Sheikh Khalifa Medical City | Abu Dhabi | United Arab Emirates | ||
| 154 | Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | United Kingdom | L14 3PE | |
| 155 | St George's University Hospitals - NHS Trust | London | United Kingdom | SW17 0QT | |
| 156 | St. George's Hospital-NHS Trust | London | United Kingdom | SW17 0QT | |
| 157 | St. Bartholomew's Hospital | London | United Kingdom | ||
| 158 | The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital | Newcastle Upon Tyne | United Kingdom | NE7 7DN |
Sponsors and Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
Investigators
- Study Director: Brien Neudeck, PharmD, Medtronic Clinical Research Director
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT02752737
Other Study ID Numbers:
- Cryo Global Registry
First Posted:
Apr 27, 2016
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Additional relevant MeSH terms: