Prior studies such as the AMADEUS, TITAN or TITAN II have shown reduction of mitral valve regurgitation (MR) with the Carillon device. This sham-controlled randomized study tested the efficacy of this device in secondary mitral regurgitation.
Primary end point was echocardiographic MR reduction (blind core lab) and secondary end point were hospitalization for cardiac failure, change in regurgitant volume and in LV end systolic and end diastolic volume.
It included 120 patients from 31 randomized centers 3:1: 87 received transcatheter annuloplasty with Carillon device (14 could not be treated) and 33 were assigned in the control group.
At one year follow up there were no differences between both groups (16.1% vs 18.2%), at intention to treat analysis, there was a 22% reduction in regurgitant volume vs an 8% increase in the control group (p=0.03).
Original title: REDUCE-FMR: A Sham-Controlled Randomized Trial of Transcatheter Mitral Valve Indirect Annuloplasty in Patients with Heart Failure and Secondary Mitral Regurgitation.
Presenter: Horst Sievert.
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