Intracardiac Echocardiography Guided Slow Pathway Cryoablation

University Medical Centre Ljubljana (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

Atrioventricular nodal reentry tachycardia is best treated with catheter ablation aimed at disruption of conduction of the slow pathway. There are currently two possible options for this ablation: radiofrequency ablation and cryoablation. The first seems to result in superior success rate, however carries a small risk of collateral damage of the heart conduction system, specifically the atrioventricular (AV) node. Cryoablation seems less effective, but safer as AV nodal damage can be avoided. The aim of this study is to prospectively test possible improved efficcacy of cryoablation of the slow pathway with the use intraprocedural intracardiac echocardiography.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    We will prospectively enroll all patients that will be referred to our center for ablation of supraventricular tachycardia and will have an electrophysiologically proven atrioventricular nodal reentry tachycardia. In order to prove the mechanism specific maneuvers will be performed during induced sustained tachycardia. Navigation in the heart will be performed in a fluoroless fashion, with the use of a three-dimensional electro-anatomic mapping (3DEAM) system. Detailed anatomical definition and navigation in the area of the Koch triangle will be done with intracardiac echocardiography (ICE). Also, in sinus rhythm, when present, the Jackman potential will be tagged on the 3DEAM map. Cryomapping will be performed at the presumed location of the slow pathway (position of the Jackman potential or only anatomical location as defined with ICE) during ongoing tachycardia with the aim to terminate it and continue with cryoablation at the successful site.

    Noninducibility will be tested with programmed and fast atrial stimulation. Patients will be followed clinically for up to 12 months.

    Study Design

    Study Type:
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Intracardiac Echocardiography Guided Slow Pathway Cryoablation for Treatment of Atrio-ventricular Nodal Reentry Tachycardia
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Jul 3, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Noninducibility at the end of procedure [up to 1 day]

      Noninducibility of AVNRT after cryoablation with programmed and fast atrial stimulation

    2. Arrhythmia free survival [12 months]

      Absence of AVNRT episodes during follow-up

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • ECG or holter ECG evidence of regular narrow QRS complex tachycardia, intraprocedural pacing maneuvers in sinus rhythm and during ongoing tachycardia indicating presence of AVNRT
    Exclusion Criteria:
    • terminal or severe medical condition with expected survival of less then 12 months, deep venous thrombosis preventing access to the femoral vein, intracardiac thrombi, anatomical irregularities of pelvic veins and/or inferior vena cava, inability to induce AVNRT after the initial induction and diagnosis - enables exclusion of procedures where accidental mechanical termination of slow pathway conduction with the cryoablation catheter occurs

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • University Medical Centre Ljubljana


    • Study Chair: Matevž Jan, MD, University Medical Centre Ljubljana

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Matevz Jan, MD, University Medical Centre Ljubljana Identifier:
    Other Study ID Numbers:
    • ICE cryo AVNRT
    First Posted:
    Jan 30, 2023
    Last Update Posted:
    Jan 30, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Matevz Jan, MD, University Medical Centre Ljubljana
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 30, 2023