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Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study

BACKGROUND: Radiofrequency ablation has been shown to be a safe and effective treatment for scar-related ventricular arrhythmias (VA). Recent preliminary studies have shown that real time integration of late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) images with electroanatomical ma...

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Autores principales: Lilli, Alessio, Parollo, Matteo, Mazzocchetti, Lorenzo, De Sensi, Francesco, Rossi, Andrea, Notarstefano, Pasquale, Santoro, Amato, Aquaro, Giovanni Donato, Cresti, Alberto, Lapira, Federica, Faggioni, Lorenzo, Tessa, Carlo, Pauselli, Luca, Bongiorni, Maria Grazia, Berruezo, Antonio, Zucchelli, Giulio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9012027/
https://www.ncbi.nlm.nih.gov/pubmed/35421939
http://dx.doi.org/10.1186/s12872-022-02581-1
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author Lilli, Alessio
Parollo, Matteo
Mazzocchetti, Lorenzo
De Sensi, Francesco
Rossi, Andrea
Notarstefano, Pasquale
Santoro, Amato
Aquaro, Giovanni Donato
Cresti, Alberto
Lapira, Federica
Faggioni, Lorenzo
Tessa, Carlo
Pauselli, Luca
Bongiorni, Maria Grazia
Berruezo, Antonio
Zucchelli, Giulio
author_facet Lilli, Alessio
Parollo, Matteo
Mazzocchetti, Lorenzo
De Sensi, Francesco
Rossi, Andrea
Notarstefano, Pasquale
Santoro, Amato
Aquaro, Giovanni Donato
Cresti, Alberto
Lapira, Federica
Faggioni, Lorenzo
Tessa, Carlo
Pauselli, Luca
Bongiorni, Maria Grazia
Berruezo, Antonio
Zucchelli, Giulio
author_sort Lilli, Alessio
collection PubMed
description BACKGROUND: Radiofrequency ablation has been shown to be a safe and effective treatment for scar-related ventricular arrhythmias (VA). Recent preliminary studies have shown that real time integration of late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) images with electroanatomical map (EAM) data may lead to increased procedure efficacy, efficiency, and safety. METHODS: VOYAGE is a prospective, randomized, multicenter controlled open label study designed to compare in terms of efficacy, efficiency, and safety a CMR aided/guided workflow to standard EAM-guided ventricular tachycardia (VT) ablation. Patients with an ICD or with ICD implantation expected within 1 month, with scar related VT, suitable for CMR and multidetector computed tomography (MDCT) will be randomized to a CMR-guided or CMR-aided approach, whereas subjects unsuitable for imaging or with image quality deemed not sufficient for postprocessing will be allocated to standard of care ablation. Primary endpoint is defined as VT recurrences (sustained or requiring appropriate ICD intervention) during 12 months follow-up, excluding the first month of blanking period. Secondary endpoints will include procedural efficiency, safety, impact on quality of life and comparison between CMR-guided and CMR-aided approaches. Patients will be evaluated at 1, 6 and 12 months. DISCUSSION: The clinical impact of real time CMR-guided/aided ablation approaches has not been thoroughly assessed yet. This study aims at defining whether such workflow results in more effective, efficient, and safer procedures. If proven to be of benefit, results from this study could be applied in large scale interventional practice. Trial registrationClinicalTrials.gov, NCT04694079, registered on January 1, 2021.
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spelling pubmed-90120272022-04-16 Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study Lilli, Alessio Parollo, Matteo Mazzocchetti, Lorenzo De Sensi, Francesco Rossi, Andrea Notarstefano, Pasquale Santoro, Amato Aquaro, Giovanni Donato Cresti, Alberto Lapira, Federica Faggioni, Lorenzo Tessa, Carlo Pauselli, Luca Bongiorni, Maria Grazia Berruezo, Antonio Zucchelli, Giulio BMC Cardiovasc Disord Study Protocol BACKGROUND: Radiofrequency ablation has been shown to be a safe and effective treatment for scar-related ventricular arrhythmias (VA). Recent preliminary studies have shown that real time integration of late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) images with electroanatomical map (EAM) data may lead to increased procedure efficacy, efficiency, and safety. METHODS: VOYAGE is a prospective, randomized, multicenter controlled open label study designed to compare in terms of efficacy, efficiency, and safety a CMR aided/guided workflow to standard EAM-guided ventricular tachycardia (VT) ablation. Patients with an ICD or with ICD implantation expected within 1 month, with scar related VT, suitable for CMR and multidetector computed tomography (MDCT) will be randomized to a CMR-guided or CMR-aided approach, whereas subjects unsuitable for imaging or with image quality deemed not sufficient for postprocessing will be allocated to standard of care ablation. Primary endpoint is defined as VT recurrences (sustained or requiring appropriate ICD intervention) during 12 months follow-up, excluding the first month of blanking period. Secondary endpoints will include procedural efficiency, safety, impact on quality of life and comparison between CMR-guided and CMR-aided approaches. Patients will be evaluated at 1, 6 and 12 months. DISCUSSION: The clinical impact of real time CMR-guided/aided ablation approaches has not been thoroughly assessed yet. This study aims at defining whether such workflow results in more effective, efficient, and safer procedures. If proven to be of benefit, results from this study could be applied in large scale interventional practice. Trial registrationClinicalTrials.gov, NCT04694079, registered on January 1, 2021. BioMed Central 2022-04-14 /pmc/articles/PMC9012027/ /pubmed/35421939 http://dx.doi.org/10.1186/s12872-022-02581-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Lilli, Alessio
Parollo, Matteo
Mazzocchetti, Lorenzo
De Sensi, Francesco
Rossi, Andrea
Notarstefano, Pasquale
Santoro, Amato
Aquaro, Giovanni Donato
Cresti, Alberto
Lapira, Federica
Faggioni, Lorenzo
Tessa, Carlo
Pauselli, Luca
Bongiorni, Maria Grazia
Berruezo, Antonio
Zucchelli, Giulio
Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study
title Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study
title_full Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study
title_fullStr Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study
title_full_unstemmed Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study
title_short Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study
title_sort ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of voyage study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9012027/
https://www.ncbi.nlm.nih.gov/pubmed/35421939
http://dx.doi.org/10.1186/s12872-022-02581-1
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