Clinical Trial Details

NCT ID: NCT01360008
Date Last Changed: January 14, 2014


Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Arrhythmia

Research Study Title

FREEZE Cohort Study


Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation will be investigated in a cohort study design in experienced electrophysiologic (EP) centers analyzing propensity-matched cohorts. Prior to participation in the cohort-study each EP center had to perform a minimum of 50 RF or 50 cryoballoon approaches. To insure the consecutiveness of recruitment, participating centers have to announce the intention to ablate the patient prior to the procedure to the coordinating center in Ludwigshafen. After inclusion of 500 patients with well accepted criteria for AF ablation undergoing cryoballoon pulmonary vein isolation (PVI) in experienced german EP centers inclusion of patients will be extended to european centers. A total of 4.000 patients will be included in the cohort-study, 2.000 in both the cryoballoon and the RF arm.

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Recruitment Details

Both Male and Female
18 and up
Overall Status
Lead Sponsor
Stiftung Institut fuer Herzinfarktforschung
49 Months
Facility Type


Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting < 1 year)

  • First ablation of AF

  • Age ≥18 years

  • Documented inefficacy of at least 1 AAD not including β-blockers

  • Written informed consent

Exclusion Criteria:

  • Longstanding persistent AF lasting > 1 year

  • 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

Site Locations (37)

Country State City Zip Facility and Contact
United States North Carolina Asheville 28803 Mission Hospital, Inc.
Joseph J Souza, MD
Austria Linz 4020 Allgemeines KH Linz
Clemens steinwender, Dr.
Germany Aschaffenburg 63739 Klinikum Aschaffenburg
Guido Groschup, Dr.
Germany Bad Krozingen Herz-Zentrum Bad Krozingen
Thomas Arentz, MD
Germany Bad Nauheim Kerckhoff-Klinik
Heinz-Friedrich Pitschner, MD
Germany Bad Neustadt 97616 Herz- und Gefäßklinik Bad Neustadt; Klinik für Kardiologie II
Thomas Deneke, Prof. Dr.
Germany Bad Oeynhausen Herz- und Diabeteszentrum
Georg Nölker, MD
Germany Berlin 13353 Deutsches Herzzentrum Berlin (Kardiologie)
Hong Gerds-Li, Prof. Dr.
Germany Berlin Vivantes Klinikum Am Urban
Dietrich Andresen, MD
Germany Bielefeld 33604 Klinikum Bielelfeld - Klinik für Kardiologie und internistische Intensivmedizin
Christoph Stellbrink, Prof. Dr.
Germany Bonn 53105 Universitätsklinikum Bonn (Med. Klinik und Poliklinik II)
Jan Schrickel, PD Dr.
Germany Coburg Klinikum Coburg
Johannes Brachmann, MD
Germany Dresden Praxisklinik Herz und Gefäße
Stefan G. Spitzer, MD
Germany Essen 45138 Elisabeth-Krankenhaus Essen; Klinik für Kardiologie und Angiologie
Georg von Sabin, Prof. Dr.
Germany Frankfurt Cardioangiologisches Centrum Bethanien - CCB
K.R. Julian Chun, MD
Germany Frankfurt 65929 Städt. Klinikum Frankfurt Höchst
Semi Sen, Prof. Dr.
Germany Hamburg Asklepios Klinik St. Georg
Karl-Heinz Kuck, MD
Germany Hamburg Universitäres Herzzentrum
Stephan Willems, MD
Germany Hamburg 20246 Universitäres Herzzentrum Eppendorf
Stephan Willems, Prof. Dr.
Germany Hannover 30449 Klinikum Siloah
Andreas Franke, Prof. Dr.
Germany Heidelberg 69120 Universitätsklinikum Heidelberg
Stefan Hardt, Prof. Dr.
Germany Hildesheim Städt. Klinikum Hildesheim
Jürgen Tebbenjohanns, MD
Germany Ingolstadt 85049 Klinikum Ingolstadt
Karlheinz Seidl, Prof. Dr.
Germany Kaiserslautern Westpfalz-Klinikum GmbH
Burghard Schumacher, MD
Germany Köln 50733 St. Vinzenz Hospital Köln-Nippes
Dinh Q Nguyen, Dr.
Germany Lübeck 23538 Universitätsklinik Schleswig-Holstein Campus Lübeck
Holger Thiele, Prof. dr.
Germany Mainz 55131 Universitätsmedizin Mainz
Thomas Muenzel, Prof. Dr.
Germany München Isar Herzzentrum München
Thorsten Lewalter, MD
Germany München Krankenhaus München Bogenhausen
Ellen Hoffmann, MD

Ellen Hoffmann, Prof. Dr.
Principal Investigator
Germany Münster Universitätsklinikum Münster
Lars Eckardt, MD
Germany Traunstein 83278 Klinikum Traunstein
Werner Moshage, Prof. Dr.
Germany Villingen-Schwenningen 78052 Schwarzwald-Baar-Klinikum Villingen-Schwenningen GmbH
Werner Jung, Prof. Dr.
Greece Athens 106 76 Evangelismos General Hospital
Michaelis Efremidis, Dr.
South Africa Johannesburg 2196 Sunninghill Hospital
Anthony Stanley, MD
South Africa Panorama 7500 Panorama Medi-Clinic
Razeen R Gopal, MD
South Africa Parktown West 2193 Milpark Hospital
I. WP Obel, MD
Spain El Palmar - Murcia 30120 University Hospital Virgen de la Arrixaca
Arcadi Garcia Alberola, Prof. Dr.

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