ClinicalTrials.gg
Enrolling by invitationNCT05705297Updated May 9, 2024

Intracardiac Echocardiography Guided Slow Pathway Cryoablation

An observational study in Atrioventricular Nodal Reentry Tachycardia, sponsored by University Medical Centre Ljubljana. Enrolling by invitation at 1 site in Slovenia. Open to participants aged 4 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by University Medical Centre Ljubljana · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
4 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Atrioventricular Nodal Reentry Tachycardia

Keywords

  • atrioventricular nodal reentry tachycardia
  • cryoablation
  • intracardiac echocardiography
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In context

Tachycardia, Atrioventricular Nodal Reentry

22 studies on the registry are indexed under Tachycardia, Atrioventricular Nodal Reentry; 5 are open to participants now.

Browse Tachycardia, Atrioventricular Nodal Reentry studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 293 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adult and pediatric patients with the body weight above 15 kg with documented regular narrow QRS complex tachycardia referred for catheter ablation in accordance with current guidelines (EHRA, AEPC and/or HRS).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Noninducibility at the end of procedure

    Noninducibility of AVNRT after cryoablation with programmed and fast atrial stimulation

    Time frame: up to 1 day

  2. Arrhythmia free survival

    Absence of AVNRT episodes during follow-up

    Time frame: 12 months

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Study locations

1 site
  • University Medical Centre Ljubljana
    Ljubljana, 1000, Slovenia
08

References and documents

Publications

  • Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available. PubMed 31504425 ↗
  • Drago F, Calvieri C, Russo MS, Remoli R, Pazzano V, Battipaglia I, Gimigliano F, Allegretti G, Silvetti MS. Low-voltage bridge strategy to guide cryoablation of typical and atypical atrioventricular nodal re-entry tachycardia in children: mid-term outcomes in a large cohort of patients. Europace. 2021 Feb 5;23(2):271-277. doi: 10.1093/europace/euaa195. PubMed 33038208 ↗
  • Pandozi C, Lavalle C, Bongiorni MG, Catalano A, Pelargonio G, Russo M, Piro A, Carbone A, Narducci ML, Galeazzi M, Ficili S, Piccolo F, Maddaluno F, Malacrida M, Colivicchi F, Segreti L. High-density mapping of Koch's triangle during sinus rhythm and typical AV nodal reentrant tachycardia: new insight. J Interv Card Electrophysiol. 2021 Sep;61(3):487-497. doi: 10.1007/s10840-020-00841-8. Epub 2020 Aug 6. PubMed 32766944 ↗
  • Brugada J, Blom N, Sarquella-Brugada G, Blomstrom-Lundqvist C, Deanfield J, Janousek J, Abrams D, Bauersfeld U, Brugada R, Drago F, de Groot N, Happonen JM, Hebe J, Yen Ho S, Marijon E, Paul T, Pfammatter JP, Rosenthal E; European Heart Rhythm Association; Association for European Paediatric and Congenital Cardiology. Pharmacological and non-pharmacological therapy for arrhythmias in the pediatric population: EHRA and AEPC-Arrhythmia Working Group joint consensus statement. Europace. 2013 Sep;15(9):1337-82. doi: 10.1093/europace/eut082. Epub 2013 Jul 12. PubMed 23851511 ↗
  • Santangeli P, Proietti R, Di Biase L, Bai R, Natale A. Cryoablation versus radiofrequency ablation of atrioventricular nodal reentrant tachycardia. J Interv Card Electrophysiol. 2014 Mar;39(2):111-9. doi: 10.1007/s10840-013-9842-2. Epub 2013 Nov 29. PubMed 24293174 ↗
  • Deisenhofer I, Zrenner B, Yin YH, Pitschner HF, Kuniss M, Grossmann G, Stiller S, Luik A, Veltmann C, Frank J, Linner J, Estner HL, Pflaumer A, Wu J, von Bary C, Ucer E, Reents T, Tzeis S, Fichtner S, Kathan S, Karch MR, Jilek C, Ammar S, Kolb C, Liu ZC, Haller B, Schmitt C, Hessling G. Cryoablation versus radiofrequency energy for the ablation of atrioventricular nodal reentrant tachycardia (the CYRANO Study): results from a large multicenter prospective randomized trial. Circulation. 2010 Nov 30;122(22):2239-45. doi: 10.1161/CIRCULATIONAHA.110.970350. Epub 2010 Nov 15. PubMed 21098435 ↗
  • Rodriguez-Entem FJ, Exposito V, Gonzalez-Enriquez S, Olalla-Antolin JJ. Cryoablation versus radiofrequency ablation for the treatment of atrioventricular nodal reentrant tachycardia: results of a prospective randomized study. J Interv Card Electrophysiol. 2013 Jan;36(1):41-5; discussion 45. doi: 10.1007/s10840-012-9732-z. Epub 2012 Oct 19. PubMed 23080326 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05705297
Responsible party
Matevz Jan (MD, University Medical Centre Ljubljana) — Principal investigator
First posted
Jan 30, 2023
Start date
Mar 1, 2023
Primary completion
Feb 1, 2026 (estimated)
Completion
Jul 3, 2027 (estimated)
Last update
May 9, 2024

Study contacts

Matevž Jan, MD
study chair · University Medical Centre Ljubljana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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