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

Sponsor
Deutsches Herzzentrum Muenchen (Other)
Overall Status
Completed
CT.gov ID
NCT00196222
Collaborator
CryoCath Technologies Inc. (Industry)
509
Enrollment
10
Locations
2
Arms
74
Duration (Months)
50.9
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: RF-ablation
  • Procedure: cryo ablation
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
509 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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)
Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Combined endpoint of safety and efficacy of cryo ablation compared with RF ablation for procedure and 6 months follow-up data. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Kerckhoffklinik GmbH EPU Bad Nauheim Germany 61231
2 Charite Berlin Virchow - Klinikum Med. Klinik Berlin Germany 13353
3 Universitaetsklinikum Bonn Med. Klinik II Bonn Germany 53105
4 Evangelisches Krankenhaus Duesseldorf Kardiologie Duesseldorf Germany 40217
5 Universitaetsklinikum Giessen EPU Giessen Germany 35392
6 Klinikum Luedenscheid Kardiologie Luedenscheid Germany 58515
7 Klinikum der Stadt Mannheim Med. Klinik I Mannheim Germany 68167
8 Deutsches Herzzentrum Muenchen Munich Germany 80636
9 Universitaetsklinikum Tuebingen Med. Klinik/Abt.III Tuebingen Germany 72076
10 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00196222
Other Study ID Numbers:
  • GE IDE No. C00403
First Posted:
Sep 20, 2005
Last Update Posted:
Jul 4, 2013
Last Verified:
Jul 1, 2013
Additional relevant MeSH terms:
Tachycardia
Tachycardia, Atrioventricular Nodal Reentry

Study Results

No Results Posted as of Jul 4, 2013