The “REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction”
(REVERSE) study was a prospective, randomized, double-blind, multi-center global study
conducted in the United States, Canada and Europe. It was designed to determine whether
biventricular pacing limited the progression of heart failure in subject clinical status as compared
to optimal medical therapy alone in subjects with asymptomatic or mild heart failure (NYHA
Class I and II, Stage C), ventricular dyssynchrony (QRS ≥120 ms), and reduced systolic left
ventricular ejection fraction (LVEF ≤40%).
Enrolled subjects were implanted with a Medtronic CRT-P or CRT-D system (depending on ICD
indication), and following successful implant were randomized in a 2:1 fashion to one of two
study arms: biventricular pacing in conjunction with optimal medical therapy (CRT ON) or
optimal medical therapy alone (CRT OFF).
In the U.S. and Canada, subjects were unblinded at 12 months and continued to be seen annually
through 5 years of follow-up. European subjects were unblinded at 24 months and were seen
annually thereafter until 5 years. It was recommended that all subjects have CRT programmed on
at the conclusion of the blinded follow-up.
The intent of the study was to show that the CRT ON group had more limited disease
progression as compared to the CRT OFF group. In addition, reverse remodeling was assessed
by comparing the change in left ventricular end systolic volume index (LVESVi) from baseline
to 12 months between the CRT ON group and the CRT OFF group.