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

Primary Purpose

Atrioventricular Nodal Reentry Tachycardia

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
RF-ablation
cryo ablation
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrioventricular Nodal Reentry Tachycardia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kerckhoffklinik GmbH EPU
  • Charite Berlin Virchow - Klinikum Med. Klinik
  • Universitaetsklinikum Bonn Med. Klinik II
  • Evangelisches Krankenhaus Duesseldorf Kardiologie
  • Universitaetsklinikum Giessen EPU
  • Klinikum Luedenscheid Kardiologie
  • Klinikum der Stadt Mannheim Med. Klinik I
  • Deutsches Herzzentrum Muenchen
  • Universitaetsklinikum Tuebingen Med. Klinik/Abt.III
  • Universitaetsklinikum Ulm Innere Med. II

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

cryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
July 3, 2013
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
CryoCath Technologies Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00196222
Brief Title
European Multicenter Study Radiofrequency (RF) Versus Cryo in Atrioventricular Nodal Reentry Tachycardia (AVNRT)
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 Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
CryoCath Technologies Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Nodal Reentry Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
Arm Title
2
Arm Type
Experimental
Arm Description
cryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
Intervention Type
Procedure
Intervention Name(s)
RF-ablation
Intervention Description
RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
Intervention Type
Procedure
Intervention Name(s)
cryo ablation
Intervention Description
Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Schmitt, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bernhard Zrenner, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerckhoffklinik GmbH EPU
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charite Berlin Virchow - Klinikum Med. Klinik
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Bonn Med. Klinik II
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Evangelisches Krankenhaus Duesseldorf Kardiologie
City
Duesseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
Universitaetsklinikum Giessen EPU
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Klinikum Luedenscheid Kardiologie
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Klinikum der Stadt Mannheim Med. Klinik I
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen Med. Klinik/Abt.III
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm Innere Med. II
City
Ulm
ZIP/Postal Code
89075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21098435
Citation
Deisenhofer I, Zrenner B, Yin YH, Pitschner HF, Kuniss M, Grossmann G, Stiller S, Luik A, Veltmann C, Frank J, Linner J, Estner HL, Pflaumer A, Wu J, von Bary C, Ucer E, Reents T, Tzeis S, Fichtner S, Kathan S, Karch MR, Jilek C, Ammar S, Kolb C, Liu ZC, Haller B, Schmitt C, Hessling G. Cryoablation versus radiofrequency energy for the ablation of atrioventricular nodal reentrant tachycardia (the CYRANO Study): results from a large multicenter prospective randomized trial. Circulation. 2010 Nov 30;122(22):2239-45. doi: 10.1161/CIRCULATIONAHA.110.970350. Epub 2010 Nov 15.
Results Reference
result

Learn more about this trial

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

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