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

This study has been completed.
Sponsor:
Collaborator:
CryoCath Technologies Inc.
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00196222
First received: September 13, 2005
Last updated: July 3, 2013
Last verified: July 2013
  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 ]

Enrollment: 509
Study Start Date: March 2003
Study Completion Date: May 2009
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00196222

Locations
Germany
Kerckhoffklinik GmbH EPU
Bad Nauheim, Germany, 61231
Charite Berlin Virchow - Klinikum Med. Klinik
Berlin, Germany, 13353
Universitaetsklinikum Bonn Med. Klinik II
Bonn, Germany, 53105
Evangelisches Krankenhaus Duesseldorf Kardiologie
Duesseldorf, Germany, 40217
Universitaetsklinikum Giessen EPU
Giessen, Germany, 35392
Klinikum Luedenscheid Kardiologie
Luedenscheid, Germany, 58515
Klinikum der Stadt Mannheim Med. Klinik I
Mannheim, Germany, 68167
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Universitaetsklinikum Tuebingen Med. Klinik/Abt.III
Tuebingen, Germany, 72076
Universitaetsklinikum Ulm Innere Med. II
Ulm, Germany, 89075
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

Publications:
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00196222     History of Changes
Other Study ID Numbers: GE IDE No. C00403
Study First Received: September 13, 2005
Last Updated: July 3, 2013
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 August 28, 2014