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

Atrioventricular Nodal Reentry Tachycardia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196222
• Other study ID #: GE IDE No. C00403
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 3, 2013
• Start date: March 2003
• Est. completion date: May 2009

Study information

• Verified date: July 2013
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: May 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrioventricular Nodal Reentry Tachycardia
• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry

Intervention

Procedure:
• RF-ablation
RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
• cryo ablation
Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

Locations

Country	Name	City	State
Germany	Kerckhoffklinik GmbH EPU	Bad Nauheim
Germany	Charite Berlin Virchow - Klinikum Med. Klinik	Berlin
Germany	Universitaetsklinikum Bonn Med. Klinik II	Bonn
Germany	Evangelisches Krankenhaus Duesseldorf Kardiologie	Duesseldorf
Germany	Universitaetsklinikum Giessen EPU	Giessen
Germany	Klinikum Luedenscheid Kardiologie	Luedenscheid
Germany	Klinikum der Stadt Mannheim Med. Klinik I	Mannheim
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Universitaetsklinikum Tuebingen Med. Klinik/Abt.III	Tuebingen
Germany	Universitaetsklinikum Ulm Innere Med. II	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	CryoCath Technologies Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined endpoint of safety and efficacy of cryo ablation compared with RF ablation for procedure and 6 months follow-up data.		6 months	No