NCT05705297|Enrolling By Invitation
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Sponsor study identifier
observational
30
1 country
1
Study Start
March 1, 2023
Actual (reported)Primary Completion
February 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 16, 2023
Actual (reported)January 30, 2023
Actual (reported)March 1, 2023
Actual (reported)February 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Noninducibility at the end of procedure
Noninducibility of AVNRT after cryoablation with programmed and fast atrial stimulation
up to 1 day
Arrhythmia free survival
Absence of AVNRT episodes during follow-up
12 months
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).
University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
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.
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.
Matevž Jan, MD
University Medical Centre Ljubljana
First Submitted
January 16, 2023
First Posted
January 30, 2023
Study Start
March 1, 2023
Actual (reported)Primary Completion
February 1, 2026
Estimated (date passed)Typical and Atypical AVNRT High-resolution Mapping
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 9, 2024
Record last verified: 2024-05
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