Modified design of stimulation of the left ventricular endocardium for cardiac resynchronization therapy in nonresponders, previously untreatable and high-risk upgrade patients (SOLVE-CRT) trial.
Journal
American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
received:
20
01
2021
accepted:
06
02
2021
pubmed:
18
2
2021
medline:
6
5
2021
entrez:
17
2
2021
Statut:
ppublish
Résumé
The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy were being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design. This article describes the revised trial and the scientific rationale for the specific changes in the protocol.
Identifiants
pubmed: 33596412
pii: S0002-8703(21)00047-8
doi: 10.1016/j.ahj.2021.02.008
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
158-162Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.