CONGRESS ABSTRACT

Background: Heart failure (HF) has a very poor prognosis in terms of mortality, quality of life, and functional capacity. When optimal medical therapy (OMT) alone is not sufficient or not well tolerated by the subject, in selected cases with cardiac conduction system disorders, it is possible to combine it with electrical therapy (cardiac resynchronization therapy, CRT), that aims to restore the cardiac contraction synchronization. In a specific group of patients with symptomatic HF despite OMT and not eligible for CRT, or who have not responded to CRT, the Cardiac Contractility Modulation (CCM) therapy might be a treatment option, validated by randomized controlled trials.   Aim: The objective of the Predict-CCM study is to evaluate the long-term clinical and instrumental response of CCM treatment in adult subjects suffering from symptomatic heart failure due to systolic left ventricular dysfunction despite OMT. End-point assessment will be performed in the entire cohort of enrolled subjects and in the sub-cohort of patients who responded to pre-implantation stress echocardiography low-dose dobutamine. The contractile reserve of the left ventricle assessed by stress echocardiography may be among the most promising indicators for this purpose.   Methods: The Predict-CCM is an observational cohort, retrospective and prospective, Italian multicenter, independent, non-profit study. Subjects participating in the study are implanted with the Optimizer Smart Mini (Impulse Dynamics-USA), capable to deliver the CCM therapy to the failing hearts. The primary end-point is the proportion of subjects with clinical response to CCM therapy at 12 months (NYHA reduction ≥ 1 class). The estimated sample size, considering a 70% clinical response to CCM therapy at 12 months, is 120 patients. A secondary end-point, among others (both clinical and instrumental), is the reduction in the number of hospitalizations or access to day hospital facilities for HF compared to the year before the study. The enrollment in the study will continue for 2 years. The follow-up period for each subject is 12 months after implantation. The study involves clinical-instrumental controls and data collection in eCRF at the time of enrollment, at implantation, at 1/6 months and at 12 months after CCM implantation.   Conclusions: This study on the electrical treatment of HF could provide new criteria for patient selection and evaluation of the outcome of CCM therapy.