Preventive substrate ablation in chronic post-myocardial infarction patients with high-risk scar characteristics for ventricular arrhythmias: rationale and design of PREVENT-VT study.


Journal

Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
ISSN: 1572-8595
Titre abrégé: J Interv Card Electrophysiol
Pays: Netherlands
ID NLM: 9708966

Informations de publication

Date de publication:
Jan 2023
Historique:
received: 03 08 2022
accepted: 03 10 2022
pubmed: 14 10 2022
medline: 18 2 2023
entrez: 13 10 2022
Statut: ppublish

Résumé

Recent studies showed that an early strategy for ventricular tachycardia (VT) ablation resulted in reduction of VT episodes or mortality. Cardiac magnetic resonance (CMR)-derived border zone channel (BZC) mass has proved to be a strong non-invasive predictor of VT in post-myocardial infarction (MI). CMR-guided VT substrate ablation proved to be safe and effective for reducing sudden cardiac death (SCD) and VA occurrence. PREVENT-VT is a prospective, randomized, multicenter, and controlled trial designed to evaluate the safety and efficacy of prophylactic CMR-guided VT substrate ablation in chronic post-MI patients with CMR-derived arrhythmogenic scar characteristics. Chronic post-MI patients with late gadolinium enhancement (LGE) CMR will be evaluated. CMR images will be post-processed and the BZC mass measured: patients with a BZC mass > 5.15 g will be eligible. Consecutive patients will be enrolled at 3 centers and randomized on a 1:1 basis to undergo a VT substrate ablation (ABLATE arm) or optimal medical treatment (OMT arm). Primary prevention ICD will be implanted following guideline recommendations, while non-ICD candidates will be implanted with an implantable cardiac monitor (ICM). The primary endpoint is a composite outcome of sudden cardiac death (SCD) or sustained monomorphic VT, either treated by an ICD or documented with ICM. Secondary endpoints are procedural safety and efficiency outcomes of CMR-guided ablation. In some patients, the first VA episode causes SCD or severe neurological damage. The aim of the PREVENT-VT is to evaluate whether primary preventive substrate ablation may be a safe and effective prophylactic therapy for reducing SCD and VA occurrence in patients with previous MI and high-risk scar characteristics based on CMR. ClinicalTrials.gov, NCT04675073, registered on January 1, 2021.

Sections du résumé

BACKGROUND BACKGROUND
Recent studies showed that an early strategy for ventricular tachycardia (VT) ablation resulted in reduction of VT episodes or mortality. Cardiac magnetic resonance (CMR)-derived border zone channel (BZC) mass has proved to be a strong non-invasive predictor of VT in post-myocardial infarction (MI). CMR-guided VT substrate ablation proved to be safe and effective for reducing sudden cardiac death (SCD) and VA occurrence.
METHODS METHODS
PREVENT-VT is a prospective, randomized, multicenter, and controlled trial designed to evaluate the safety and efficacy of prophylactic CMR-guided VT substrate ablation in chronic post-MI patients with CMR-derived arrhythmogenic scar characteristics. Chronic post-MI patients with late gadolinium enhancement (LGE) CMR will be evaluated. CMR images will be post-processed and the BZC mass measured: patients with a BZC mass > 5.15 g will be eligible. Consecutive patients will be enrolled at 3 centers and randomized on a 1:1 basis to undergo a VT substrate ablation (ABLATE arm) or optimal medical treatment (OMT arm). Primary prevention ICD will be implanted following guideline recommendations, while non-ICD candidates will be implanted with an implantable cardiac monitor (ICM). The primary endpoint is a composite outcome of sudden cardiac death (SCD) or sustained monomorphic VT, either treated by an ICD or documented with ICM. Secondary endpoints are procedural safety and efficiency outcomes of CMR-guided ablation.
DISCUSSION CONCLUSIONS
In some patients, the first VA episode causes SCD or severe neurological damage. The aim of the PREVENT-VT is to evaluate whether primary preventive substrate ablation may be a safe and effective prophylactic therapy for reducing SCD and VA occurrence in patients with previous MI and high-risk scar characteristics based on CMR.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov, NCT04675073, registered on January 1, 2021.

Identifiants

pubmed: 36227461
doi: 10.1007/s10840-022-01392-w
pii: 10.1007/s10840-022-01392-w
doi:

Substances chimiques

Contrast Media 0
Gadolinium AU0V1LM3JT

Banques de données

ClinicalTrials.gov
['NCT04675073']

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

39-47

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Références

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Auteurs

Giulio Falasconi (G)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.
Campus Clínic, University of Barcelona, Barcelona, Spain.

Diego Penela (D)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

David Soto-Iglesias (D)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

Pietro Francia (P)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.
Cardiology, Department of Clinical and Molecular Medicine, St. Andrea Hospital, Sapienza University, Rome, Italy.

Cheryl Teres (C)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

Daniel Viveros (D)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.
Campus Clínic, University of Barcelona, Barcelona, Spain.

Aldo Bellido (A)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

Jose Alderete (J)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.
Campus Clínic, University of Barcelona, Barcelona, Spain.

Julia Meca-Santamaria (J)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

Paula Franco (P)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

Augusto Ordoñez (A)

El Pilar Hospital, Barcelona, Spain.

Marta Díaz-Escofet (M)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

Maria Matiello (M)

Catalunya General University Hospital, Barcelona, Spain.

Giuliana Maldonado (G)

Catalunya General University Hospital, Barcelona, Spain.

Claudia Scherer (C)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

Marina Huguet (M)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

Óscar Cámara (Ó)

Pompeu Fabra University, Barcelona, Spain.

José-Tomás Ortiz-Pérez (JT)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.
Campus Clínic, University of Barcelona, Barcelona, Spain.

Julio Martí-Almor (J)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.

Antonio Berruezo (A)

Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain. antonio.berruezo@quironsalud.es.

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