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

German Heart Center Munich

Status and phase

Completed

Phase 4

Conditions

Atrioventricular Nodal Reentry Tachycardia

Treatments

Procedure: cryo ablation

Procedure: RF-ablation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00196222

GE IDE No. C00403

Details and patient eligibility

About

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.

Full 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.

Enrollment

509 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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