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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Atrioventricular Nodal Reentry Tachycardia

Intervention / Treatment
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* Procedure: RF-ablation
* Procedure: cryo ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia | Procedure: RF-ablation<br>* RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia<br>|
| Experimental: 2<br>cryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia | Procedure: cryo ablation<br>* Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |