Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4071 participants
OBSERVATIONAL
2011-04-30
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cryo ablation
Patients with first Ablation of atrial fibrillation treated by cryo ablation
No interventions assigned to this group
RF ablation
Patients with first Ablation of atrial fibrillation treated by Radio frequency ablation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* First ablation of AF
* Age ≥18 years
* Documented inefficacy of at least 1 AAD not including β-blockers
* Written informed consent
Exclusion Criteria
* Acute coronary syndrome (ACS)
* Heart failure NYHA IV
* Thrombocytosis, thrombocytopenia
* Any condition contraindicating chronic anticoagulation
* Stroke or TIA within 6 months prior to ablation
* Uncontrolled hyperthyroidism
* Pregnancy
* Life expectancy \< 1 year
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Stiftung Institut fuer Herzinfarktforschung
OTHER
Responsible Party
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Principal Investigators
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Ellen Hoffmann, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Bogenhausen, München
Locations
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Mission Hospital, Inc.
Asheville, North Carolina, United States
Allgemeines KH Linz
Linz, , Austria
Klinikum Aschaffenburg
Aschaffenburg, , Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, , Germany
Kerckhoff-Klinik
Bad Nauheim, , Germany
Herz- und Gefäßklinik Bad Neustadt; Klinik für Kardiologie II
Bad Neustadt an der Saale, , Germany
Herz- und Diabeteszentrum
Bad Oeynhausen, , Germany
Deutsches Herzzentrum Berlin (Kardiologie)
Berlin, , Germany
Vivantes Klinikum Am Urban
Berlin, , Germany
Klinikum Bielelfeld - Klinik für Kardiologie und internistische Intensivmedizin
Bielefeld, , Germany
Universitätsklinikum Bonn (Med. Klinik und Poliklinik II)
Bonn, , Germany
Klinikum Coburg
Coburg, , Germany
St. Vinzenz Hospital Köln-Nippes
Cologne, , Germany
Praxisklinik Herz und Gefäße
Dresden, , Germany
Elisabeth-Krankenhaus Essen; Klinik für Kardiologie und Angiologie
Essen, , Germany
Städt. Klinikum Frankfurt Höchst
Frankfurt, , Germany
Cardioangiologisches Centrum Bethanien - CCB
Frankfurt, , Germany
Universitäres Herzzentrum Eppendorf
Hamburg, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Universitäres Herzzentrum
Hamburg, , Germany
Klinikum Siloah
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Städt. Klinikum Hildesheim
Hildesheim, , Germany
Klinikum Ingolstadt
Ingolstadt, , Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, , Germany
Universitätsklinik Schleswig-Holstein Campus Lübeck
Lübeck, , Germany
Universitätsmedizin Mainz
Mainz, , Germany
Isar Herzzentrum München
München, , Germany
Krankenhaus München Bogenhausen
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Klinikum Traunstein
Traunstein, , Germany
Schwarzwald-Baar-Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, , Germany
Evangelismos General Hospital
Athens, , Greece
Sunninghill Hospital
Johannesburg, , South Africa
Panorama Medi-Clinic
Panorama, , South Africa
Milpark Hospital
Parktown West, , South Africa
University Hospital Virgen de la Arrixaca
El Palmar - Murcia, , Spain
Countries
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References
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Pongratz J, Kuniss M, Wu L, Tebbenjohanns J, Nolker G, Dorwarth U, Kuck KH, Jochen S, Hoffmann E, Straube F; FREEZE Cohort Study Investigators. Impact of intracardiac echocardiography usage on the safety of cryoballoon atrial fibrillation ablation: Subanalysis of the prospective FREEZE cluster cohort study. J Cardiovasc Electrophysiol. 2023 Oct;34(10):2029-2039. doi: 10.1111/jce.16060. Epub 2023 Sep 8.
Metzner A, Straube F, Tilz RR, Kuniss M, Noelker G, Tebbenjohanns J, Andresen D, Wieneke H, Stellbrink C, Franke J, Dorwarth U, Carion PL, Holbrook R, Hochadel M, Senges J, Hoffmann E, Kuck KH; FREEZE Cohort Study Investigators. Electrophysiology lab efficiency comparison between cryoballoon and point-by-point radiofrequency ablation: a German sub-analysis of the FREEZE Cohort study. BMC Cardiovasc Disord. 2023 Jan 9;23(1):8. doi: 10.1186/s12872-022-03015-8.
Hoffmann E, Straube F, Wegscheider K, Kuniss M, Andresen D, Wu LQ, Tebbenjohanns J, Noelker G, Tilz RR, Chun JKR, Franke A, Stellbrink C, Garcia-Alberola A, Dorwarth U, Metzner A, Ouarrak T, Brachmann J, Kuck KH, Senges J; FREEZE Cohort Study Investigators. Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation. Europace. 2019 Sep 1;21(9):1313-1324. doi: 10.1093/europace/euz155.
Straube F, Dorwarth U, Ammar-Busch S, Peter T, Noelker G, Massa T, Kuniss M, Ewertsen NC, Chun KR, Tebbenjohanns J, Tilz R, Kuck KH, Ouarrak T, Senges J, Hoffmann E; FREEZE Cohort Investigators. First-line catheter ablation of paroxysmal atrial fibrillation: outcome of radiofrequency vs. cryoballoon pulmonary vein isolation. Europace. 2016 Mar;18(3):368-75. doi: 10.1093/europace/euv271. Epub 2015 Oct 25.
Straube F, Dorwarth U, Vogt J, Kuniss M, Heinz Kuck K, Tebbenjohanns J, Garcia Alberola A, Chun KR, Souza JJ, Ouarrak T, Senges J, Brachmann J, Lewalter T, Hoffmann E. Differences of two cryoballoon generations: insights from the prospective multicentre, multinational FREEZE Cohort Substudy. Europace. 2014 Oct;16(10):1434-42. doi: 10.1093/europace/euu162. Epub 2014 Jul 3.
Other Identifiers
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FREEZE
Identifier Type: -
Identifier Source: org_study_id
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