Academic Journal
Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial
| Title: | Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial |
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| Authors: | Azarnoush, Kasra, Pereira, Bruno, Dualé, Christian, Dorigo, Enrica, Farhat, Mehdi, Innorta, Andrea, Dauphin, Nicolas, Geoffroy, Etienne, Chabrot, Pascal, Camilleri, Lionel |
| Contributors: | Service Chirurgie Cardio-Vasculaire CHU Clermont-Ferrand, CHU Gabriel Montpied Clermont-Ferrand, CHU Clermont-Ferrand-CHU Clermont-Ferrand-Pôle Médico-Chirurgical des pathologies Cardio-Vasculaires, CHU Clermont-Ferrand-CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de la Recherche Agronomique (INRA)-Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université, Service Biostatistiques, Télématiques, Traitement de l’image CHU Clermont-Ferrand, CHU Clermont-Ferrand-CHU Clermont-Ferrand-Pôle Santé Publique CHU Clermont-Ferrand, Centre d'Investigation Clinique CHU Clermont-Ferrand (CIC 1405), Institut National de la Santé et de la Recherche Médicale (INSERM)-Direction de la Recherche Clinique et de l’Innovation CHU Clermont-Ferrand (DRCI), Service Imagerie Médicale et Radiologie Interventionnelle - site Gabriel-Montpied CHU Clermont-Ferrand, CHU Clermont-Ferrand-CHU Gabriel Montpied Clermont-Ferrand, CHU Clermont-Ferrand-Pôle Imagerie diagnostique et Radiologie Interventionnelle, CHU Clermont-Ferrand, French Ministry of Health, Edwards Lifesciences (Irvine, CA, USA), St. Jude Medical (Minneapolis, MN, USA), and Sorin Group (Saluggia, Italy) |
| Source: | ISSN: 1745-6215 ; Trials ; https://inserm.hal.science/inserm-00916944 ; Trials, 2013, 14 (1), pp.413. ⟨10.1186/1745-6215-14-413⟩. |
| Publisher Information: | CCSD BioMed Central |
| Publication Year: | 2013 |
| Collection: | Inserm: HAL (Institut national de la santé et de la recherche médicale) |
| Subject Terms: | Stented pericardial aortic valves, Pericardial aortic valves, Hemodynamic performance, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie |
| Description: | International audience ; Background Aortic valve stenosis is one of the most common heart diseases in older patients. Nowadays, surgical aortic valve replacement is the 'gold standard' treatment for this pathology and the most implanted prostheses are biological ones. The three most implanted bovine bioprostheses are the Trifecta valve (St. Jude Medical, Minneapolis, MN, USA), the Mitroflow valve (Sorin Group, Saluggia, Italy), and the Carpentier-Edwards Magna Ease valve (Edwards Lifesciences, Irvine, CA, USA). We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses. Methods and design First, we will measure the aortic annulus diameter using CT-scan, echocardiography and by direct sizing in the operating room after native aortic valve resection. The accuracy of information, in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers, will be checked. Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery. Discussion This prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses. The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient's morphological characteristics. Trial registration ClinicalTrials.gov Identifier: NCT01522352 |
| Document Type: | article in journal/newspaper |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/24299218; PRODINRA: 259915; PUBMED: 24299218; WOS: 000328757900001 |
| DOI: | 10.1186/1745-6215-14-413 |
| Availability: | https://inserm.hal.science/inserm-00916944 https://inserm.hal.science/inserm-00916944v1/document https://inserm.hal.science/inserm-00916944v1/file/1745-6215-14-413.pdf https://doi.org/10.1186/1745-6215-14-413 |
| Rights: | info:eu-repo/semantics/OpenAccess |
| Accession Number: | edsbas.6EFB67D0 |
| Database: | BASE |
| DOI: | 10.1186/1745-6215-14-413 |
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