Systolic Left Ventricular Dysfunction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEC-MIC system
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.
Sponsors
Berlin Heals GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study objective is to assess the safety of the C-MIC System in case of system extended use or abandonment or explantation in patients having received a C-MIC System in the context of a prior study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have received a C-MIC System during the C-MIC-II Study. * Informed consent in writing from the patient.
Exclusion criteria
* Patients who are unwilling or unable to participate in the study visits. * Vulnerable Patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 2 years | Rate of all cause, cardiac and device related mortality |
| Hospitalizations | 2 years | Rate of all-cause, cardiac and device related hospitalizations |
| Adverse events | 2 years | Overall incidence and severity of adverse events including malfunction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in New York Heart Association (NYHA) classification | 2 years | NYHA functional class |
| Change in cardiac performance | 2 Years | Left ventricular ejection fraction |
| Change in aerobic capacity and endurance | 2 years | 6 Minute walk test |
| Cange in exercise ability | 2 years | Cardiopulmonary exercise test |
| Treatment adjustment | 2 Years | Need for prolonged therapy with the C-MIC System in responder patients |
| Patient related outcome | 2 years | Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status |
Countries
Bosnia and Herzegovina, Croatia, North Macedonia, Serbia
Contacts
Primary ContactPeter Goettel, MD
Backup ContactKersten Brandes, MD
Outcome results
None listed