FREEZE Cohort Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Stiftung Institut fuer Herzinfarktforschung
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01360008
First received: May 13, 2011
Last updated: January 14, 2014
Last verified: July 2013
  Purpose

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.


Condition
Arrhythmia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FREEZE Cohort Study

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up [ Time Frame: Admission to hospital until 12 months thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of complication rates (any complications and major complications) at 12 months follow-up [ Time Frame: Admission to hospital until 12 months thereafter ] [ Designated as safety issue: Yes ]
  • Specific complication aspects with respect to phrenic nerve palsy and PV stenosis [ Time Frame: Admission to Hospital until 12 months thereafter ] [ Designated as safety issue: Yes ]
  • Efficacy (AF recurrency rates), safety (complication rates), and procedural parameters in cryoballoon or RF ablation as means for assessing advantages of preprocedural CT or MRI scan performing 3 D anatomy of the left atrium and pulmonary veins [ Time Frame: Admission to Hospital until 12 months thereafter ] [ Designated as safety issue: No ]
  • Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI [ Time Frame: Admission to Hospital until 12 months thereafter ] [ Designated as safety issue: No ]
  • Real-time ECG-monitoring of PV-isolation during freezing: Does the microcircular mapping catheter add significant benefit to the cryoballoon procedure [ Time Frame: Admission to Hospital until 12 months thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: April 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with AF ablation targeting

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360008

Locations
United States, North Carolina
Mission Hospital, Inc. Recruiting
Asheville, North Carolina, United States, 28803
Contact: Joseph J Souza, MD       jsouza@avlcard.com   
Austria
Allgemeines KH Linz Recruiting
Linz, Austria, 4020
Contact: Clemens steinwender, Dr.       clemens.steinwender@akh.Linz.at   
Germany
Klinikum Aschaffenburg Recruiting
Aschaffenburg, Germany, 63739
Contact: Guido Groschup, Dr.       rhythmologie@klinikum-aschaffenburg.de   
Herz-Zentrum Bad Krozingen Recruiting
Bad Krozingen, Germany
Contact: Thomas Arentz, MD       thomas.arentz@herzzentrum.de   
Kerckhoff-Klinik Recruiting
Bad Nauheim, Germany
Contact: Heinz-Friedrich Pitschner, MD       h.pitschner@kerckhoff-klinik.de   
Herz- und Gefäßklinik Bad Neustadt; Klinik für Kardiologie II Recruiting
Bad Neustadt, Germany, 97616
Contact: Thomas Deneke, Prof. Dr.       thomas.deneke@kardiologie-bad-neustadt.de   
Herz- und Diabeteszentrum Recruiting
Bad Oeynhausen, Germany
Contact: Georg Nölker, MD       gnoelker@hdz-nrw.de   
Deutsches Herzzentrum Berlin (Kardiologie) Recruiting
Berlin, Germany, 13353
Contact: Hong Gerds-Li, Prof. Dr.       gerds-li@DHZB.de   
Vivantes Klinikum Am Urban Recruiting
Berlin, Germany
Contact: Dietrich Andresen, MD       Dietrich.Andresen@vivantes.de   
Klinikum Bielelfeld - Klinik für Kardiologie und internistische Intensivmedizin Recruiting
Bielefeld, Germany, 33604
Contact: Christoph Stellbrink, Prof. Dr.       christoph.stellbrink@sk-bielefeld.de   
Universitätsklinikum Bonn (Med. Klinik und Poliklinik II) Recruiting
Bonn, Germany, 53105
Contact: Jan Schrickel, PD Dr.       Jan.Schrickel@ukb.uni-bonn.de   
Klinikum Coburg Recruiting
Coburg, Germany
Contact: Johannes Brachmann, MD       johannes.brachmann@klinikum-coburg.de   
Praxisklinik Herz und Gefäße Recruiting
Dresden, Germany
Contact: Stefan G. Spitzer, MD       prof.spitzer@praxisklinik-dresden.de   
Elisabeth-Krankenhaus Essen; Klinik für Kardiologie und Angiologie Recruiting
Essen, Germany, 45138
Contact: Georg von Sabin, Prof. Dr.       g.v.sabin@contilia.de   
Cardioangiologisches Centrum Bethanien - CCB Recruiting
Frankfurt, Germany
Contact: K.R. Julian Chun, MD       j.chun@ccb.de   
Städt. Klinikum Frankfurt Höchst Recruiting
Frankfurt, Germany, 65929
Contact: Semi Sen, Prof. Dr.       Semi.Sen@skfh.de   
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany
Contact: Karl-Heinz Kuck, MD       k.kuck@asklepios.com   
Universitäres Herzzentrum Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Stephan Willems, Prof. Dr.       willems@uke.uni-hamburg.de   
Universitäres Herzzentrum Recruiting
Hamburg, Germany
Contact: Stephan Willems, MD       willems@uke.uni-hamburg.de   
Klinikum Siloah Recruiting
Hannover, Germany, 30449
Contact: Andreas Franke, Prof. Dr.       andreas.franke@krh.eu   
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Stefan Hardt, Prof. Dr.       sekretariat_katus@med.uni-heidelberg.de/stefan.hardt@med.uni-heidelberg.de   
Städt. Klinikum Hildesheim Recruiting
Hildesheim, Germany
Contact: Jürgen Tebbenjohanns, MD       j.tebbenjohanns@stk-hildesheim.de   
Klinikum Ingolstadt Recruiting
Ingolstadt, Germany, 85049
Contact: Karlheinz Seidl, Prof. Dr.       karlheinz.Seidl@klinikum-ingolstadt.de   
Westpfalz-Klinikum GmbH Recruiting
Kaiserslautern, Germany
Contact: Burghard Schumacher, MD       bschumacher@westpfalz-klinikum.de   
St. Vinzenz Hospital Köln-Nippes Recruiting
Köln, Germany, 50733
Contact: Dinh Q Nguyen, Dr.       dinh.nguyen@vinzenz-hospital.de   
Universitätsklinik Schleswig-Holstein Campus Lübeck Recruiting
Lübeck, Germany, 23538
Contact: Holger Thiele, Prof. dr.       holger.thiele@uksh.de   
Universitätsmedizin Mainz Recruiting
Mainz, Germany, 55131
Contact: Thomas Muenzel, Prof. Dr.       tmuenzel@uni-mainz.de   
Isar Herzzentrum München Recruiting
München, Germany
Contact: Thorsten Lewalter, MD       Thorsten.Lewalter@isarkliniken.de   
Krankenhaus München Bogenhausen Recruiting
München, Germany
Contact: Ellen Hoffmann, MD       ellen.hoffmann@klinikum-muenchen.de   
Principal Investigator: Ellen Hoffmann, Prof. Dr.         
Universitätsklinikum Münster Recruiting
Münster, Germany
Contact: Lars Eckardt, MD       l.eckardt@uni-muenster.de   
Klinikum Traunstein Recruiting
Traunstein, Germany, 83278
Contact: Werner Moshage, Prof. Dr.       Werner.Moshage@klinikum-traunstein.de   
Schwarzwald-Baar-Klinikum Villingen-Schwenningen GmbH Recruiting
Villingen-Schwenningen, Germany, 78052
Contact: Werner Jung, Prof. Dr.       werner.jung@sbk-vs.de   
Greece
Evangelismos General Hospital Recruiting
Athens, Greece, 106 76
Contact: Michaelis Efremidis, Dr.       micefraim@gmail.com   
South Africa
Sunninghill Hospital Recruiting
Johannesburg, South Africa, 2196
Contact: Anthony Stanley, MD       anthys@netactive.co.za   
Panorama Medi-Clinic Recruiting
Panorama, South Africa, 7500
Contact: Razeen R Gopal, MD       rrgopal@telkomsa.net   
Milpark Hospital Recruiting
Parktown West, South Africa, 2193
Contact: I. WP Obel, MD       proobel@netactive.co.za   
Spain
University Hospital Virgen de la Arrixaca Recruiting
El Palmar - Murcia, Spain, 30120
Contact: Arcadi Garcia Alberola, Prof. Dr.       arcadi@secardiologia.es   
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Medtronic
Investigators
Principal Investigator: Ellen Hoffmann, MD Klinikum Bogenhausen, München
  More Information

No publications provided

Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01360008     History of Changes
Other Study ID Numbers: FREEZE
Study First Received: May 13, 2011
Last Updated: January 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Cardiac arrhythmia
Catheter ablation
Cohort Study
cryoballoon
radiofrequency

ClinicalTrials.gov processed this record on September 18, 2014