The goal of this observational cohort study, which is both retrospective and prospective, is to evaluate the long-term clinical and instrumental response to Cardiac Contractility Modulation (CCM) treatment in adult subjects suffering from symptomatic heart failure (HF) due to systolic left ventricular dysfunction, despite adequate medical therapy. Based on the response to stress echocardiography with preimplantation low-dose Dobutamine, the main questions it aims to answer are:
* What is the proportion of subjects who experience a clinical response to CCM therapy at 12 months (NYHA reduction ≥ 1 class)? * There was a reduction in the number of hospitalizations, visits to the Emergency Department, and access to day hospital facilities for more than 4 hours compared to the year before the study (e.g., by intravenous infusion of cardiac inotropic drugs)? * What is the estimated change in the quality-of-life score using the "Quality of Life Questionnaire with Heart Failure - Minnesota" (MLHFQ) between baseline and the end of follow-up? * What is the change in walking distance between baseline and the end of the follow-up in the walk test (6MWT) (optional)? * What is the difference in NT-proBNP levels between baseline and the end of follow-up? Participants are already receiving CCM support as part of their regular medical care for heart failure.
Subject of both sexes with age ≥ 18 years,
Ability to understand and sign informed consent to participate in the study and consent to process sensitive personal data.
Carrier of symptomatic heart failure, despite optimal medical therapy (OMT),
Reduced left ventricular systolic function (E.F. <50%),
Life expectancy < 1 year due to non-cardiac comorbidities that reduce prognosis,
Presence of contraindications to the CCM implantation procedure (absence of vascular access usable for CCM implantation, active infectious processes, active severe coagulopathies, presence of mechanical tricuspid valve),
Contraindications to the performance of the echocardiographic test under pharmacological stress (heart failure in progress, myocardial infarction in the acute phase, acute inflammatory processes of the heart muscle and/or pericardium, critical aortic valve stenosis and severe obstructions to left ventricular outflow, dissecting aneurysm of the aorta, severe arrhythmias not controlled by therapy, known hypersensitivity to the drug, intraventricular thrombi).
Enrollable subjects who, in the participating Clinical Centers, received a CCM implant from July 1, 2024, to the start of the study will be part of the retrospective cohort, while subsequent subjects of the prospective cohort.
Cohort
Other
Cardiac Contractility Modulation (CCM) implant
DeviceSubjects participating in the study carry or will carry the Cardiac Contractility Modulation (CCM) medical device "OPTIMIZER Smart Mini" by Impulse Dynamics (USA). It is indicated for use in patients over 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction, despite appropriate medical treatment. The OPTIMIZER Smart Mini Implantable Pulse Generator is a programmable device with an internal battery and telemetry functions. The OPTIMIZER Smart Mini is connected to two or three implantable leads, two of which are implanted in the right ventricle and one, optionally, in the right atrium.
New York Heart Association class variation
The proportion of subjects with clinical response to CCM therapy at 12 months, defined as a reduction of at least 1 class of the New York Heart Association Classification of the functional status of the heart (minimum value I, better outcome, and maximum value IV, worse outcome)
Hospitalizations
Change in the number of hospitalizations, visits to the Emergency Department, or access to day hospital facilities for more than 4 hours (e.g., by intravenous infusion of cardiac inotropic drugs) compared to the year before the study.
Minnesota LIVING WITH HEART FAILURE Questionnaire score variation
Change in the quality-of-life score estimated with the "Minnesota LIVING WITH HEART FAILURE Questionnaire" MLHFQ (minimum value 0, better outcome, and maximum value 105, worse outcome),
6MWT variation
Change in walk distance between baseline and end of follow-up in the walk test (6MWT)
NT-proBNP variation
Change in NT-proBNP level between baseline and end of follow-up
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Quovadis Associazione
Lead sponsor
Impulse Dynamics
Collaborator
