Goldberg Steven L, Meredith Ian, Marwick Thomas, Haluska Brian A, Lipiecki Janusz, Siminiak Tomasz, Mehta Nawzer, Kaye David M, Sievert Horst
Tyler Heart Institute at Community Hospital of the Monterey Peninsula, Monterey, WA; Cardiac Dimensions, Kirkland, WA.
Monash University, Melbourne, Australia.
Am Heart J. 2017 Jun;188:167-174. doi: 10.1016/j.ahj.2017.02.032. Epub 2017 Mar 6.
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.
已在3项非随机试验中对Carillon二尖瓣轮廓系统进行了研究，这些试验的对象为有症状的充血性心力衰竭和功能性二尖瓣反流患者。REDUCE FMR研究是一项设计独特的双盲试验，评估Carillon装置对减少反流容积的影响，并评估该装置的安全性和临床疗效。Carillon是一种基于冠状窦的间接瓣环成形术装置。符合条件的患者接受侵入性静脉造影，以评估冠状窦静脉对Carillon装置的适用性。如果静脉尺寸合适，他们将按3:1的比例随机分组，以决定是否接受该装置。患者和评估人员对治疗分配情况不知情。主要终点是植入组和未植入组在1年时反流容积的差异。其他比较包括临床参数，如心力衰竭住院情况、6分钟步行试验、堪萨斯城心肌病问卷（KCCQ）以及其他超声心动图参数。还将纳入一项运动超声心动图子研究。
