A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure-Trial design of the REDUCE FMR study.
Identifieur interne : 001269 ( Main/Exploration ); précédent : 001268; suivant : 001270A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure-Trial design of the REDUCE FMR study.
Auteurs : Steven L. Goldberg [États-Unis] ; Ian Meredith [Australie] ; Thomas Marwick [Australie] ; Brian A. Haluska [Australie] ; Janusz Lipiecki [France] ; Tomasz Siminiak [Pologne] ; Nawzer Mehta [États-Unis] ; David M. Kaye [Australie] ; Horst Sievert [Royaume-Uni]Source :
- American heart journal [ 1097-6744 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Annuloplastie mitrale (instrumentation), Cathétérisme cardiaque (), Conception d'appareillage, Conception de prothèse, Défaillance cardiaque (), Défaillance cardiaque (diagnostic), Femelle, Humains, Insuffisance mitrale (), Insuffisance mitrale (diagnostic), Insuffisance mitrale (étiologie), Mâle, Méthode en double aveugle, Prothèse valvulaire cardiaque, Résultat thérapeutique, Sujet âgé, Valve atrioventriculaire gauche (), Valve atrioventriculaire gauche (imagerie diagnostique), Échocardiographie, Études de suivi, Études prospectives.
- MESH :
- diagnostic : Défaillance cardiaque, Insuffisance mitrale.
- imagerie diagnostique : Valve atrioventriculaire gauche.
- étiologie : Annuloplastie mitrale, Insuffisance mitrale.
- Adulte d'âge moyen, Cathétérisme cardiaque, Conception d'appareillage, Conception de prothèse, Défaillance cardiaque, Femelle, Humains, Insuffisance mitrale, Mâle, Méthode en double aveugle, Prothèse valvulaire cardiaque, Résultat thérapeutique, Sujet âgé, Valve atrioventriculaire gauche, Échocardiographie, Études de suivi, Études prospectives.
English descriptors
- KwdEn :
- Aged, Cardiac Catheterization (methods), Double-Blind Method, Echocardiography, Equipment Design, Female, Follow-Up Studies, Heart Failure (complications), Heart Failure (diagnosis), Heart Failure (surgery), Heart Valve Prosthesis, Humans, Male, Middle Aged, Mitral Valve (diagnostic imaging), Mitral Valve (surgery), Mitral Valve Annuloplasty (instrumentation), Mitral Valve Insufficiency (diagnosis), Mitral Valve Insufficiency (etiology), Mitral Valve Insufficiency (surgery), Prospective Studies, Prosthesis Design, Treatment Outcome.
- MESH :
- complications : Heart Failure.
- diagnosis : Heart Failure, Mitral Valve Insufficiency.
- diagnostic imaging : Mitral Valve.
- etiology : Mitral Valve Insufficiency.
- instrumentation : Mitral Valve Annuloplasty.
- methods : Cardiac Catheterization.
- surgery : Heart Failure, Mitral Valve, Mitral Valve Insufficiency.
- Aged, Double-Blind Method, Echocardiography, Equipment Design, Female, Follow-Up Studies, Heart Valve Prosthesis, Humans, Male, Middle Aged, Prospective Studies, Prosthesis Design, Treatment Outcome.
Abstract
The Carillon Mitral Contour System has been studied in 3 nonrandomized trials in patients with symptomatic congestive heart failure and functional mitral regurgitation. The REDUCE FMR study is a uniquely designed, double-blind trial evaluating the impact of the Carillon device on reducing regurgitant volume, as well as assessing the safety and clinical efficacy of this device. Carillon is a coronary sinus-based indirect annuloplasty device. Eligible patients undergo an invasive venogram to assess coronary sinus vein suitability for the Carillon device. If the venous dimensions are suitable, they are randomized on a 3:1 basis to receive a device or not. Patients and assessors are blinded to the treatment assignment. The primary end point is the difference in regurgitant volume at 1 year between the implanted and nonimplanted groups. Other comparisons include clinical parameters such as heart failure hospitalizations, 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and other echocardiographic parameters. An exercise echo substudy will also be included.
DOI: 10.1016/j.ahj.2017.02.032
PubMed: 28577672
Affiliations:
- Australie, France, Pologne, Royaume-Uni, États-Unis
- Auvergne (région administrative), Auvergne-Rhône-Alpes, Victoria (État), Washington (État)
- Clermont-Ferrand, Melbourne
Links toward previous steps (curation, corpus...)
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Le document en format XML
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<author><name sortKey="Sievert, Horst" sort="Sievert, Horst" uniqKey="Sievert H" first="Horst" last="Sievert">Horst Sievert</name>
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<series><title level="j">American heart journal</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term>
<term>Cardiac Catheterization (methods)</term>
<term>Double-Blind Method</term>
<term>Echocardiography</term>
<term>Equipment Design</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Heart Failure (complications)</term>
<term>Heart Failure (diagnosis)</term>
<term>Heart Failure (surgery)</term>
<term>Heart Valve Prosthesis</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Mitral Valve (diagnostic imaging)</term>
<term>Mitral Valve (surgery)</term>
<term>Mitral Valve Annuloplasty (instrumentation)</term>
<term>Mitral Valve Insufficiency (diagnosis)</term>
<term>Mitral Valve Insufficiency (etiology)</term>
<term>Mitral Valve Insufficiency (surgery)</term>
<term>Prospective Studies</term>
<term>Prosthesis Design</term>
<term>Treatment Outcome</term>
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<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Annuloplastie mitrale (instrumentation)</term>
<term>Cathétérisme cardiaque ()</term>
<term>Conception d'appareillage</term>
<term>Conception de prothèse</term>
<term>Défaillance cardiaque ()</term>
<term>Défaillance cardiaque (diagnostic)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Insuffisance mitrale ()</term>
<term>Insuffisance mitrale (diagnostic)</term>
<term>Insuffisance mitrale (étiologie)</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Prothèse valvulaire cardiaque</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Valve atrioventriculaire gauche ()</term>
<term>Valve atrioventriculaire gauche (imagerie diagnostique)</term>
<term>Échocardiographie</term>
<term>Études de suivi</term>
<term>Études prospectives</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Heart Failure</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Heart Failure</term>
<term>Mitral Valve Insufficiency</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Défaillance cardiaque</term>
<term>Insuffisance mitrale</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en"><term>Mitral Valve</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Mitral Valve Insufficiency</term>
</keywords>
<keywords scheme="MESH" qualifier="imagerie diagnostique" xml:lang="fr"><term>Valve atrioventriculaire gauche</term>
</keywords>
<keywords scheme="MESH" qualifier="instrumentation" xml:lang="en"><term>Mitral Valve Annuloplasty</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Cardiac Catheterization</term>
</keywords>
<keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Heart Failure</term>
<term>Mitral Valve</term>
<term>Mitral Valve Insufficiency</term>
</keywords>
<keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Annuloplastie mitrale</term>
<term>Insuffisance mitrale</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Double-Blind Method</term>
<term>Echocardiography</term>
<term>Equipment Design</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Heart Valve Prosthesis</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Prospective Studies</term>
<term>Prosthesis Design</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Cathétérisme cardiaque</term>
<term>Conception d'appareillage</term>
<term>Conception de prothèse</term>
<term>Défaillance cardiaque</term>
<term>Femelle</term>
<term>Humains</term>
<term>Insuffisance mitrale</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Prothèse valvulaire cardiaque</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Valve atrioventriculaire gauche</term>
<term>Échocardiographie</term>
<term>Études de suivi</term>
<term>Études prospectives</term>
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<front><div type="abstract" xml:lang="en">The Carillon Mitral Contour System has been studied in 3 nonrandomized trials in patients with symptomatic congestive heart failure and functional mitral regurgitation. The REDUCE FMR study is a uniquely designed, double-blind trial evaluating the impact of the Carillon device on reducing regurgitant volume, as well as assessing the safety and clinical efficacy of this device. Carillon is a coronary sinus-based indirect annuloplasty device. Eligible patients undergo an invasive venogram to assess coronary sinus vein suitability for the Carillon device. If the venous dimensions are suitable, they are randomized on a 3:1 basis to receive a device or not. Patients and assessors are blinded to the treatment assignment. The primary end point is the difference in regurgitant volume at 1 year between the implanted and nonimplanted groups. Other comparisons include clinical parameters such as heart failure hospitalizations, 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and other echocardiographic parameters. An exercise echo substudy will also be included.</div>
</front>
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<li>France</li>
<li>Pologne</li>
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<tree><country name="États-Unis"><region name="Washington (État)"><name sortKey="Goldberg, Steven L" sort="Goldberg, Steven L" uniqKey="Goldberg S" first="Steven L" last="Goldberg">Steven L. Goldberg</name>
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<name sortKey="Mehta, Nawzer" sort="Mehta, Nawzer" uniqKey="Mehta N" first="Nawzer" last="Mehta">Nawzer Mehta</name>
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<country name="Australie"><region name="Victoria (État)"><name sortKey="Meredith, Ian" sort="Meredith, Ian" uniqKey="Meredith I" first="Ian" last="Meredith">Ian Meredith</name>
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<name sortKey="Haluska, Brian A" sort="Haluska, Brian A" uniqKey="Haluska B" first="Brian A" last="Haluska">Brian A. Haluska</name>
<name sortKey="Kaye, David M" sort="Kaye, David M" uniqKey="Kaye D" first="David M" last="Kaye">David M. Kaye</name>
<name sortKey="Marwick, Thomas" sort="Marwick, Thomas" uniqKey="Marwick T" first="Thomas" last="Marwick">Thomas Marwick</name>
</country>
<country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Lipiecki, Janusz" sort="Lipiecki, Janusz" uniqKey="Lipiecki J" first="Janusz" last="Lipiecki">Janusz Lipiecki</name>
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</country>
<country name="Pologne"><noRegion><name sortKey="Siminiak, Tomasz" sort="Siminiak, Tomasz" uniqKey="Siminiak T" first="Tomasz" last="Siminiak">Tomasz Siminiak</name>
</noRegion>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Sievert, Horst" sort="Sievert, Horst" uniqKey="Sievert H" first="Horst" last="Sievert">Horst Sievert</name>
</noRegion>
</country>
</tree>
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</record>
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