Clinical trial NCT00196222: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrioventricular Nodal Reentry Tachycardia
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: CryoCath Technologies Inc.
First posted: 2005-09-20
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Combined endpoint of safety and efficacy of cryo ablation compared with RF ablation for procedure and 6 months follow-up data.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoffklinik GmbH EPU
city: Berlin
country: Germany
facility: Charite Berlin Virchow - Klinikum Med. Klinik
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn Med. Klinik II
city: Duesseldorf
country: Germany
facility: Evangelisches Krankenhaus Duesseldorf Kardiologie
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen EPU
city: Luedenscheid
country: Germany
facility: Klinikum Luedenscheid Kardiologie
city: Mannheim
country: Germany
facility: Klinikum der Stadt Mannheim Med. Klinik I
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen Med. Klinik/Abt.III
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm Innere Med. II
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Claus Schmitt, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Bernhard Zrenner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.