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European Multicenter Study Radiofrequency (RF) Versus Cryo in Atrioventricular Nodal Reentry Tachycardia (AVNRT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
CryoCath Technologies Inc.
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00196222
First received: September 13, 2005
Last updated: September 11, 2008
Last verified: March 2008
History of Changes
  Purpose

In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia are compared: The standard technique of radiofrequency energy delivery is compared with the new approach of cryo-energy application.


Condition Intervention Phase
Atrioventricular Nodal Reentry Tachycardia
 Procedure: RF-ablation
Procedure: cryo ablation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: European Multicenter Study RF Versus Cryo in AVNRT: A Randomized Study Comparing Cryo-Energy vs. Radiofrequency-Energy Ablation Technique for AV Nodal Reentry Tachycardia (AVNRT)

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Combined endpoint of safety and efficacy of cryo ablation compared with RF ablation for procedure and 6 months follow-up data. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2003
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
 Procedure: RF-ablation
RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
Experimental: 2
cryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
 Procedure: cryo ablation
Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

Detailed Description:

The ablation of AV nodal reentry tachycardia with radiofrequency (RF) energy delivering catheters is a standard procedure and in experienced EP laboratories, the safety and efficacy of this approach is very high.

However, the potential complication of higher degree AV conduction block, requiring in some instances implantation of a pacemaker, is a major drawback of this approach.

We want to compare in this randomized study the safety and efficacy of standard RF ablation with the cryo-ablation technique. This relatively new technique is thought to offer more safety concerning higher degree AV conduction block.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 80 years old
  • Clinical diagnosis of AVNRT (ECG/patients history)
  • Electrophysiologically confirmed (invasively assessed) diagnosis of AVNRT
  • Written informed consent

Exclusion Criteria:

  • Prior ablation for AVNRT
  • Congenital heart disease interfering with the ablation method
  • Prior cardiac surgery
  • Medical or psychiatric disorder interfering with study protocol or data acquisition
  • Exclusion of the patient by the study investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196222

Contacts
Contact: Bernhard Zrenner, MD 0049 89 1218-2020 zrenner@dhm.mhn.de

Locations
Germany
Kerckhoffklinik GmbH EPU Recruiting
Bad Nauheim, Germany, 61231
Contact: Heinz Pitschner, MD     +496032 / 996-0     h.pitschner@kerckhoff-klinik.de    
Sub-Investigator: Heinz Pitschner, MD            
Charite Berlin Virchow - Klinikum Med. Klinik Recruiting
Berlin, Germany, 13353
Contact: Wilhelm Haverkamp, MD     +4930 / 450 553 366     wilhelm.haverkamp@charite.de    
Sub-Investigator: Wilhelm Harverkamp, MD            
Universitaetsklinikum Bonn Med. Klinik II Recruiting
Bonn, Germany, 53105
Contact: Th. Lewalter, MD     +49228 / 287 6670     th.lewalter@uni-bonn.de    
Sub-Investigator: Th. Lewalter, MD            
Evangelisches Krankenhaus Duesseldorf Kardiologie Recruiting
Duesseldorf, Germany, 40217
Contact: Vester, MD     +49221 / 919 1855     kardiologie@evk-duesseldorf.de    
Sub-Investigator: Vester, MD            
Universitaetsklinikum Giessen EPU Recruiting
Giessen, Germany, 35392
Contact: Ali Erdogan, MD     +49641 / 994 3400     ali.erdogan@med.uni-giessen.de    
Sub-Investigator: Ali Erdogan, MD            
Klinikum Luedenscheid Kardiologie Recruiting
Luedenscheid, Germany, 58515
Contact: Bernd Lemke, MD     +492351 / 463326     Bernd.Lemke@ruhr-uni-bochum.de    
Sub-Investigator: Bernd Lemke, MD            
Klinikum der Stadt Mannheim Med. Klinik I Recruiting
Mannheim, Germany, 68167
Contact: Susanne Spehl, MD     +49621 / 383-2204     susanne.spehl@med.ma.uni-heidelberg.de    
Sub-Investigator: Susanne Spehl, MD            
Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany, 80636
Contact: Bernhard Zrenner, MD     0049 89 1218-2020     zrenner@dhm.mhn.de    
Principal Investigator: Bernhard Zrenner, MD            
Universitaetsklinikum Tuebingen Med. Klinik/Abt.III Recruiting
Tuebingen, Germany, 72076
Contact: Mathias Busch         mathias.busch@med.uni-tuebingen.de    
Sub-Investigator: Mathias Busch, MD            
Universitaetsklinikum Ulm Innere Med. II Recruiting
Ulm, Germany, 89075
Contact: Georg Großmann, MD         georg.rossmann@medizin.uni-ulm.de    
Sub-Investigator: Georg Großmann, MD            
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
CryoCath Technologies Inc.
Investigators
Study Chair: Claus Schmitt, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Bernhard Zrenner, MD Deutsches Herzzentrum Muenchen
  More Information

No publications provided by Deutsches Herzzentrum Muenchen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00196222     History of Changes
Other Study ID Numbers: GE IDE No. C00403
Study First Received: September 13, 2005
Last Updated: September 11, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Atrioventricular Nodal Reentry
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Tachycardia, Reciprocating

ClinicalTrials.gov processed this record on June 18, 2013