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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196222

Enrollment

509

Registered

2005-09-20

Start date

2003-03-31

Completion date

2009-05-31

Last updated

2013-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrioventricular Nodal Reentry Tachycardia

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.

Interventions

PROCEDURERF-ablation

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

PROCEDUREcryo ablation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026