Trial Information

FREEZE Cohort Study

Official Title: FREEZE Cohort Study

Summary

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.

Phase: N/A

Sponsor: Stiftung Institut fuer Herzinfarktforschung

Locations (14)

Country	State	City	Zip	Facility and Contact
Germany		Bad Krozingen		Herz-Zentrum Bad Krozingen Thomas Arentz, MD thomas.arentz@herzzentrum.de
Germany		Bad Nauheim		Kerckhoff-Klinik Heinz-Friedrich Pitschner, MD h.pitschner@kerckhoff-klinik.de
Germany		Bad Oeynhausen		Herz- und Diabeteszentrum Jürgen Vogt, MD jvogt@hdz-nrw.de
Germany		Berlin		Vivantes Klinikum Am Urban Dietrich Andresen, MD Dietrich.Andresen@vivantes.de
Germany		Coburg		Klinikum Coburg Johannes Brachmann, MD johannes.brachmann@klinikum-coburg.de
Germany		Dresden		Praxisklinik Herz und Gefäße Stefan G. Spitzer, MD prof.spitzer@praxisklinik-dresden.de
Germany		Frankfurt		Cardioangiologisches Centrum Bethanien - CCB K.R. Julian Chun, MD j.chun@ccb.de
Germany		Hamburg		Universitäres Herzzentrum Stephan Willems, MD willems@uke.uni-hamburg.de
Germany		Hamburg		Asklepios Klinik St. Georg Karl-Heinz Kuck, MD k.kuck@asklepios.com
Germany		Hildesheim		Städt. Klinikum Hildesheim Johannes Brachmann, MD j.tebbenjohanns@stk-hildesheim.de
Germany		Kaiserslautern		Westpfalz-Klinikum GmbH Burghard Schumacher, MD bschumacher@westpfalz-klinikum.de
Germany		München		Isar Herzzentrum München Thorsten Lewalter, MD Thorsten.Lewalter@isarkliniken.de
Germany		München		Krankenhaus München Bogenhausen Ellen Hoffmann, MD ellen.hoffmann@klinikum-muenchen.de
Germany		Münster		Universitätsklinikum Münster Lars Eckardt, MD l.eckardt@uni-muenster.de

NCT ID:NCT01360008

Date Last Changed: May 23, 2011