European Multicenter Study Radiofrequency (RF) Versus Cryo in Atrioventricular Nodal Reentry Tachycardia (AVNRT) - Full Text View

Sponsors and Collaborators:	Deutsches Herzzentrum Muenchen CryoCath Technologies Inc.
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00196222

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 IV

Study Type:

Interventional

Study Design:

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

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
1: Experimental 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
2: Experimental 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
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
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
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
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
Evangelisches Krankenhaus Duesseldorf Kardiologie	Recruiting
Duesseldorf, Germany, 40217
Contact: Vester, MD +49221 / 919 1855 kardiologie@evk-duesseldorf.de
Sub-Investigator: Vester, 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

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

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

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Tachycardia, Atrioventricular Nodal Reentry
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases

Tachycardia, Reciprocating
Tachycardia, Atrioventricular Nodal Reentry
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 03, 2009