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

Phase 4CompletedNCT00196222

Deutsches Herzzentrum Muenchen509 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

509

Conditions

Atrioventricular Nodal Reentry Tachycardia

Interventions

RF-ablationPROCEDURE

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

cryo ablationPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (10)

Kerckhoffklinik GmbH EPU

Bad Nauheim, Germany

Charite Berlin Virchow - Klinikum Med. Klinik

Berlin, Germany

Universitaetsklinikum Bonn Med. Klinik II

Bonn, Germany

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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