MARC details
| 000 -LEADER |
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| fixed length control field |
03873nam a22005417a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
220124s20212021 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
0002-8703 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1016/j.ahj.2021.09.011 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
S0002-8703(21)00240-4 [pii] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
34587510 |
| 245 ## - TITLE STATEMENT |
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| Title |
Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial). |
| 251 ## - Source |
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| Source |
American Heart Journal. 243:92-102, 2022 01. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Am Heart J. 243:92-102, 2022 01. |
| 252 ## - Abbreviated Source |
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| Former abbreviated source |
Am Heart J. 243:92-102, 2022 Jan. |
| 253 ## - Journal Name |
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| Journal name |
American heart journal |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Publication date |
2022 Jan |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
ppublish |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2021-11-01 |
| 268 ## - Previous citation |
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| -- |
American Heart Journal. 243:92-102, 2022 Jan. |
| 501 ## - WITH NOTE |
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| Local holdings |
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov, Unique identifier: NCT04722250. Copyright (c) 2021 Elsevier Inc. All rights reserved. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient >=20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or >=moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Aortic Valve Stenosis |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Heart Valve Prosthesis |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Transcatheter Aortic Valve Replacement |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aortic Valve/dg [Diagnostic Imaging] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aortic Valve/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Female |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prospective Studies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prosthesis Design |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Risk Factors |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Severity of Illness Index |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Transcatheter Aortic Valve Replacement/mt [Methods] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Outcome |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Rogers, Toby |
| 790 ## - Authors |
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| All authors |
Abdel-Wahab M, Attizzani GF, Batchelor W, Bleiziffer S, Chang Y, Gada H, Gillam L, Guerrero M, Herrmann HC, Mahoney PD, Mehran R, Petronio AS, Rogers T, Rovin J, Szerlip M, Tchetche D, Verdoliva S, Whisenant B |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1016/j.ahj.2021.09.011">https://dx.doi.org/10.1016/j.ahj.2021.09.011</a> |
| Public note |
https://dx.doi.org/10.1016/j.ahj.2021.09.011 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
