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

July 3, 2013 updated by: Deutsches Herzzentrum Muenchen

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

509

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoffklinik GmbH EPU
      • Berlin, Germany, 13353
        • Charite Berlin Virchow - Klinikum Med. Klinik
      • Bonn, Germany, 53105
        • Universitaetsklinikum Bonn Med. Klinik II
      • Duesseldorf, Germany, 40217
        • Evangelisches Krankenhaus Duesseldorf Kardiologie
      • Giessen, Germany, 35392
        • Universitaetsklinikum Giessen EPU
      • Luedenscheid, Germany, 58515
        • Klinikum Luedenscheid Kardiologie
      • Mannheim, Germany, 68167
        • Klinikum der Stadt Mannheim Med. Klinik I
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen Med. Klinik/Abt.III
      • Ulm, Germany, 89075
        • Universitaetsklinikum Ulm Innere Med. II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
Procedure: RF-ablation
RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
EXPERIMENTAL: 2
cryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
Procedure: cryo ablation
Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

CryoCath Technologies Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 4, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. C00403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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