The C-MIC-II Follow-Up Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: C-MIC system.
- Who it may be relevant to
- Registry conditions: Systolic Left Ventricular Dysfunction. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bosnia and Herzegovina, Croatia, North Macedonia, Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device C-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.
Primary outcome measures
- Mortality [Time frame: 2 years]
- Hospitalizations [Time frame: 2 years]
- Adverse events [Time frame: 2 years]
Secondary outcome measures (6)
- Change in cardiac performance [Time frame: 2 Years]
- Treatment adjustment [Time frame: 2 Years]
- Patient related outcome [Time frame: 2 years]
- Change in New York Heart Association (NYHA) classification [Time frame: 2 years]
- Cange in exercise ability [Time frame: 2 years]
- Change in aerobic capacity and endurance [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bosnia and Herzegovina · 2 centers
- University Clinical Centre of Republic of Srpska — Banja Luka
- University Clinical Center of Sarajevo — Sarajevo
Serbia · 2 centers
- Clinical Center of Serbia — Belgrade
- Clinical Hospital Center Bezanijska Kosa — Belgrade
Croatia · 1 center
- Clinical Hospital Dubrava — Zagreb
North Macedonia · 1 center
- University Clinic Cardiac Surgery — Skopje
Identifiers
NCT: NCT05189860 · C-MIC-II-FU