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Completed

NCT Number: NCT00196222

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

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.

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Key information

Conditions

Atrioventricular Nodal Reentry Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Atrioventricular Nodal Reentry Tachycardia, Reciprocating

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kerckhoffklinik GmbH EPU, Bad Nauheim, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RF-ablation

Procedure

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

cryo ablation

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • CryoCath Technologies Inc.

Registry information

Official study 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)

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Jul 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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