The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart. Target patients for this study are patients who have received the device in a prior study.
The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart. The therapy with the C-MIC System is intended to take 6 months. The C-MIC System consists of four parts, of which three are implanted: a transvenous and an epicardial lead and a power source to which the leads are connected. Both leads have the function to transmit micro-current to the heart. A Portable User Terminal (PUT) is needed for programming and readout of the data recorded by the Implantable Microcurrent Device (IMD). Target patients of the C-MIC System at the time of implantation and inclusion in the C-MICII Study were patients with idiopathic dilative cardiomyopathy (NYHA class III - NYHA class who have systolic left ventricular dysfunction despite adequate therapy of heart failure. Target patients for this study are patients who have received the device in a prior study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
This study aims to follow up patients already treated with a C-MIC System over a period of 2 years following the initial treatment with the device, to assess the long term results.
University Clinical Centre of Republic of Srpska
Banja Luka, Banja Luka, Bosnia and Herzegovina
NOT_YET_RECRUITINGUniversity Clinical Center of Sarajevo
Sarajevo, Sarajevo, Bosnia and Herzegovina
NOT_YET_RECRUITINGClinical Hospital Dubrava
Zagreb, City of Zagreb, Croatia
Mortality
Rate of all cause, cardiac and device related mortality
Time frame: 2 years
Hospitalizations
Rate of all-cause, cardiac and device related hospitalizations
Time frame: 2 years
Adverse events
Overall incidence and severity of adverse events including malfunction
Time frame: 2 years
Change in cardiac performance
Left ventricular ejection fraction
Time frame: 2 Years
Treatment adjustment
Need for prolonged therapy with the C-MIC System in responder patients
Time frame: 2 Years
Patient related outcome
Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status
Time frame: 2 years
Change in New York Heart Association (NYHA) classification
NYHA functional class
Time frame: 2 years
Cange in exercise ability
Cardiopulmonary exercise test
Time frame: 2 years
Change in aerobic capacity and endurance
6 Minute walk test
Time frame: 2 years
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University Clinic Cardiac Surgery
Skopje, North Macedonia
RECRUITINGClinical Center of Serbia
Belgrade, Serbia
RECRUITINGClinical Hospital Center Bezanijska Kosa
Belgrade, Serbia
RECRUITING