Non-Excitatory, Cardiac Contractility Modulation Electrical Impulses: Feasibility Study for Advanced Heart Failure in Patients with Normal QRS Duration

Clinical trials update from the Heart Failure Society of America meeting: FIX‐CHF‐4, selective cardiac myosin activator and OPT‐CHF

“…There were some baseline imbalances between the treatment groups for LVEF and peak VO 2 , which make interpretation of the results difficult. Although the study showed some interesting trends, due to the small number of patients none of these achieved statistical significance [4].…”

Cardiac Contractility Modulation for Heart Failure: A Meta‐Analysis of Randomized Controlled Trials

“…Neelagaru et al 31,32 observed an increase in peak VO 2 (0.2 mL/kg/min) in the treatment group compared to the control group although both groups showed a steady decline from baseline over the 24‐week period. In FIX‐CHF‐4, peak VO 2 increased slightly in both groups in the first phase, after which peak VO 2 remained higher in the group switched from sham to CCM (0.16 ± 2.50 mL/kg/min) and decreased in those crossed from CCM to sham (–0.86 ± 3.06 mL/kg/min) 33 .…”

“…This was assessed using the MLWHFQ and measured in 629 participants. Data from Neelagaru et al 31,32 and first arm crossover of FIX‐CHF‐4 were meta‐analyzed and showed no significant effect of CCM in improving MLWHFQ (n = 213; WMD –2.17, 95% CI –4.79 to 0.45, P = 0.10; Fig. 6).…”

“…All studies used the OPTIMIZER™ System as the intervention and control groups consisted of either sham treatment (Neelagaru et al 31,32 and FIX‐CHF‐4) 33 or optimal medical therapy (FIX‐HF‐5) 34–36 . One trial (Neelagaru et al 31,32 ) was conducted in a single institution whereas the other two were multicenter studies. Withdrawals and associated reasons were described in all trials and no evidence of selective outcome reporting was observed.…”

“…Trial design varied across studies. Neelagaru et al 31,32 was a randomized, controlled, double‐blind, feasibility study aimed to determine the efficacy and safety of CCM. The small sample size of this pilot study made definitive efficacy or safety assessment difficult.…”