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

Phase 4

Completed

• Conditions: Atrioventricular Nodal Reentry Tachycardia
• Interventions: Procedure: RF-ablation; Procedure: cryo ablation

• Registration Number: NCT00196222
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-20
• Primary Completion: 2008-11
• Study Completion: 2009-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-03
• Last Update Posted: 2013-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RF-ablation	RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
2	cryo ablation	cryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

Primary Outcome Measures

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

Trial Locations

Locations (10)

Kerckhoffklinik GmbH EPU; 🇩🇪 Bad Nauheim, Germany

Charite Berlin Virchow - Klinikum Med. Klinik; 🇩🇪 Berlin, Germany

Universitaetsklinikum Giessen EPU; 🇩🇪 Giessen, Germany

Evangelisches Krankenhaus Duesseldorf Kardiologie; 🇩🇪 Duesseldorf, Germany

Universitaetsklinikum Bonn Med. Klinik II; 🇩🇪 Bonn, Germany

Klinikum Luedenscheid Kardiologie; 🇩🇪 Luedenscheid, Germany

Universitaetsklinikum Tuebingen Med. Klinik/Abt.III; 🇩🇪 Tuebingen, Germany

Klinikum der Stadt Mannheim Med. Klinik I; 🇩🇪 Mannheim, Germany

Universitaetsklinikum Ulm Innere Med. II; 🇩🇪 Ulm, Germany

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany