124281 - A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure.pdf (284.32 kB)View fileThis item contains files with download restrictions
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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
posted on 2023-05-22, 03:24authored byGoldberg, SL, Meredith, I, Marwick, T, Haluska, BA, Lipiecki, J, Siminiak, T, Mehta, N, Kaye, DM, Sievert, H
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.
History
Publication title
American Heart Journal
Volume
188
Pagination
167-174
ISSN
0002-8703
Department/School
Menzies Institute for Medical Research
Publisher
Mosby
Place of publication
Inc, 11830 Westline Industrial Dr, St Louis, USA, Mo, 63146-3318