Systolic Left Ventricular DysfunctionC-MIC-II-FUNCT05189860
The C-MIC-II Follow-Up Study
A study testing C-MIC system in people with Systolic Left Ventricular Dysfunction, run by Berlin Heals GmbH at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systolic Left Ventricular Dysfunction
- What is being tested?
- C-MIC system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 3 Mar 2022to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have received a C-MIC System during the C-MIC-II Study.
- Informed consent in writing from the patient.
Who cannot join
- Patients who are unwilling or unable to participate in the study visits.
- Vulnerable Patients.
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Bosnia and Herzegovina2 sites, 2 recruiting
- Not yet recruiting
University Clinical Centre of Republic of Srpska
Banja Luka, Banja Luka, 78000
- Not yet recruiting
University Clinical Center of Sarajevo
Sarajevo, Sarajevo, 71000
Serbia2 sites, 2 recruiting
- Recruiting
Clinical Center of Serbia
Belgrade
- Recruiting
Clinical Hospital Center Bezanijska Kosa
Belgrade
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Dubrava
Zagreb, City of Zagreb, 10000
Igor Rudez, MD
North Macedonia1 site, 1 recruiting
- Recruiting
University Clinic Cardiac Surgery
Skopje, 1000
About this 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.
Target patients for this study are patients who have received the device in a prior study.
Read the 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.
- Conditions
- Systolic Left Ventricular Dysfunction
- Being tested
- C-MIC system
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MIC systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| C-MIC Device | Experimental | Device plus Standard of Care Receives: Device: C-MIC system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Rate of all cause, cardiac and device related mortality
Measured: 2 years
Hospitalizations
Rate of all-cause, cardiac and device related hospitalizations
Measured: 2 years
Adverse events
Overall incidence and severity of adverse events including malfunction
Measured: 2 years
Secondary outcomes (6)
Change in cardiac performance
Left ventricular ejection fraction
Measured: 2 Years
Treatment adjustment
Need for prolonged therapy with the C-MIC System in responder patients
Measured: 2 Years
Patient related outcome
Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status
Measured: 2 years
Change in New York Heart Association (NYHA) classification
NYHA functional class
Measured: 2 years
Cange in exercise ability
Cardiopulmonary exercise test
Measured: 2 years
Change in aerobic capacity and endurance
6 Minute walk test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start3 Mar 2022
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berlin Heals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Goettel, MD, Study chair, Berlin Heals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189860
- Sponsor's protocol ID
- C-MIC-II-FU
- Acronym
- C-MIC-II-FU
- Status last verified
- Jun 2025
- First submitted
- 27 Dec 2021
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The C-MIC-II Follow-Up Study
- ClinicalTrials.gov ID
- NCT05189860
- Acronym / sponsor ID
- C-MIC-II-FU / C-MIC-II-FU
- Conditions
- Systolic Left Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Berlin Heals GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| C-MIC Device | Experimental | Device: C-MIC systemDevice plus Standard of Care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have received a C-MIC System during the C-MIC-II Study.
- Informed consent in writing from the patient.
Key exclusion criteria (2 listed)
- Patients who are unwilling or unable to participate in the study visits.
- Vulnerable Patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-MIC systemThis 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. | Device | C-MIC Device |
Primary outcome
Mortality
Time frame: 2 years
Rate of all cause, cardiac and device related mortality
Hospitalizations
Time frame: 2 years
Rate of all-cause, cardiac and device related hospitalizations
Adverse events
Time frame: 2 years
Overall incidence and severity of adverse events including malfunction
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Parent trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Goettel, MD study chair
Berlin Heals GmbH
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-MIC system in people with Systolic Left Ventricular Dysfunction, run by Berlin Heals GmbH at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Bosnia and Herzegovina, Serbia, Croatia, North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Goettel, MD (+49 30 88913640 ext. 61, goettel@berlinheals.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.