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

Steven L Goldberg, Ian Meredith, Thomas Marwick, Brian A Haluska, Janusz Lipiecki, Tomasz Siminiak, Nawzer Mehta, David M. Kaye, Horst Sievert

Research output: Contribution to journalArticleOtherpeer-review

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.

Original languageEnglish
Pages (from-to)167-174
Number of pages8
JournalAmerican Heart Journal
Volume188
DOIs
Publication statusPublished - 1 Jun 2017

Cite this

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title = "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",
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.",
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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. / Goldberg, Steven L; Meredith, Ian; Marwick, Thomas; Haluska, Brian A; Lipiecki, Janusz; Siminiak, Tomasz; Mehta, Nawzer; Kaye, David M.; Sievert, Horst.

In: American Heart Journal, Vol. 188, 01.06.2017, p. 167-174.

Research output: Contribution to journalArticleOtherpeer-review

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