Impulse Dynamics has successfully completed three major clinical studies, the results of which have been published in leading medical journals. The studies have shown CCM therapy to be safe and effective in the treatment of heart failure patients. The Optimizer system has been implanted in over 1,500 patients to date, and has accumulated over 8 years of follow up data.
FIX-CHF-3 (Europe) – a multi-center study
Twenty-five patients with drug-refractory, NYHA Class III heart failure were implanted with a CCM pulse generator.Symptoms of Heart failure significantly improved from NYHA Class III to Class II in 15 patients and to Class I in 4 patients (p<0.000001), left ventricular ejection fraction improved from 22±7% to 28±8% (p=0.0002) and the Minnesota Living with Heart Failure Score (MLWHFS) improved from 43±22 to 25±18 (p=0.001). The 6-minutes walk test increased from 411±86 to 465±81 meters (p=0.02). The study conclusion was that CCM, by delivering intermittent non-excitatory electric stimuli is a promising technique for improving ventricular systolic function and symptoms in patients with drug-refractory NYHA Class III heart failure.
FIX-CHF-4 (Europe) – a multi-center, randomized, double blind study
164 subjects with EF<35% and NYHA Class II (24%) or III (76%) symptoms received a CCM pulse generator. Patients were randomly assigned to Group 1 (n=80, CCM treatment first 3 months, sham treatment for following 3 months) or Group 2 (n=84, sham treatment first 3 months, CCM treatment for consecutive 3 months). Data from therapy ON periods were pooled between the groups and data from therapy OFF periods were pooled between groups. CCM increased peak VO2 by 0.52±1.39 ml/kg/min (p=0.03) and improved Minnesota Living with Heart Failure Questionnaire (MLWHFQ) by 3 units (p=0.03)(Figure below). Overall, in patients with chronic heart failure and left ventricular dysfunction, CCM signals were safe and improved exercise tolerance and quality of life with as little as 3-months of treatment.
FIX-HF-5 Feasibility Trial (US) – a multi-center, randomized, double blind study
This study included 49 subjects with EF<35%, normal QRS duration (105±15 ms) and NYHA Class III or IV despite medical therapy. Patients were randomized to receive CCM pulse generator (Treatment, n=25) or to remain off (Control, n=24) for 6 months. Evaluations included NYHA, 6-minute walk, cardiopulmonary stress test, Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and 24-hour Holter monitoring. CCM treatment increased freedom from death or hospitalization of any cause at 6 months (84% vs 62%).
FIX-HF-5 Pivotal Trial (US) – a multi-center, randomized, unblinded study
This study included 428 patients with NYHA Class III or IV symptoms and EF≤35% who were randomized to receive either an Optimizer III System implant plus Optimal Medical Management (OMM, n=215) or OMM alone (n=213). The primary safety endpoint was a comparison between groups of the composite of all cause mortality and all-cause hospitalization (in a non-inferiority analysis) through one year of treatment; this endpoint was reached.
In the overall population, CCM improved peak VO2, quality of life (indexed by MLWHFQ) and NYHA but not anaerobic threshold (the study’s primary endpoint). Furthermore, in a pre-specified subgroup analysis consisting of about 50% of the overall population characterized by baseline EF≥25% and NYHA III symptoms, CCM improved anaerobic threshold, peak VO2, MLWHFQ and NYHA by particularly large and statistically significant amounts (Figure below).
Presented as late breaking clinical trial at American College of Cardiology annual meeting, March 2008, Chicago.