ACTIVE is a multicenter randomized trial of the Edwards Cardioband System (Edwards Lifesciences, Irvine, CA) for the treatment of patients with clinically significant functional mitral regurgitation. Patients are randomized in 2:1 fashion to the Edwards Cardioband System plus guideline directed medical therapy or guideline directed medical therapy alone. 375 participants will be enrolled. Estimated primary completion date is September 2020. The primary outcome is one-year prevalence of MR ≤ 2+ and hierarchical comparison of device and control groups including time to cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved). In the early experience of 60 patients with moderate or severe functional MR on guideline medical therapy, procedural success was achieved in 68% (41/60) patients. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively.
All Editors: Kalkidan Bishu, MD, FSCAI
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