Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial).
Aortic stenosis
Prothesis-patient mismatch (PPM)
Randomized trial
Transcatheter aortic valve replacement (TAVR)
Journal
American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
received:
21
07
2021
accepted:
20
09
2021
pubmed:
30
9
2021
medline:
8
4
2022
entrez:
29
9
2021
Statut:
ppublish
Résumé
The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials. The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women. URL: www.clinicaltrials.gov, Unique identifier: NCT04722250.
Sections du résumé
BACKGROUND
The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials.
METHODS
The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm
CONCLUSIONS
The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women.
CLINICAL TRIAL REGISTRATION
URL: www.clinicaltrials.gov, Unique identifier: NCT04722250.
Identifiants
pubmed: 34587510
pii: S0002-8703(21)00240-4
doi: 10.1016/j.ahj.2021.09.011
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04722250']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
92-102Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.