Study of Implantable Cardiac Contractility Modulation Therapy for Adults with Heart Failure and Ejection Fraction Between 40% and 70%

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Cardiac Contractility Modulation CCM therapy in people with heart failure who have a left ventricular ejection fraction LVEF between 40% and 70%. This clinical trial is designed as a multi-center, randomized, quadruple-blind, sham-controlled study to compare CCM therapy delivered through the OPTIMIZER Smart Mini System against a sham control. The trial includes two parts the first focuses on functional capacity and health status, while the second examines clinical outcomes. Participants will have the OPTIMIZER Smart Mini System implanted and be randomly assigned in a 21 ratio to either receive active CCM therapy CCM ON or sham therapy CCM OFF for the first 18 months. CCM therapy involves delivering seven one-hour treatment phases spread evenly over each 24-hour period. After 18 months, those initially in the sham group will have CCM therapy activated. Part I of the trial enrolls 450 participants, who will be followed through Part II, which includes up to an additional 1,050 participants. During the study, participants will undergo screening and baseline evaluations before device implantation. Researchers will assess changes in walking distance using a 6-minute walk test and health status via the Kansas City Cardiomyopathy Questionnaire at 6 months. Safety will be monitored by tracking device- or procedure-related complications over 12 months. The study will also evaluate a composite of mortality, morbidity, and health status outcomes up to 18 months. The total duration of participant involvement spans up to 18 months with ongoing follow-up and monitoring.

Assessment of CCM in HF With Higher Ejection Fraction