Systolic Left Ventricular DysfunctionC-MIC-IINCT04662034
Performance and Safety of the Cardiac Microcurrent Therapy System
A study testing CMIC in people with Systolic Left Ventricular Dysfunction, run by Berlin Heals GmbH at 20 sites in 11 countries.
Trial summary
Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according to treatment guidelines of heart failure and who have a baseline left ventricular ejection fraction of ≥25% and ≤35 will receive a C-MIC System and microcurrent therapy… 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?
- CMIC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 20 sitesin 11 countries
- Study dates
- 5 Feb 2021to 13 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA III - IV (ambulatory)).
- Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening.
- Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by echocardiography within 30 days prior to study inclusion.
- Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic human study and about the intended treatment period of 6 months which is derived by the fact that according to current knowledge microcurrent treatment exceeding 6 months will not have additional favorable effects which means will not further improve cardiac function. Accordingly, battery life is limited. Furthermore, the patient is informed about the possibility for device explantation, informed regarding possible risks and is able to give written informed consent prior to any procedures and is considered willing and able to adhere to study regimen and to return for all follow-up visits.
- Patients are receiving guideline conform heart failure therapy
- Patients receiving appropriate, stable guideline conform anti-heart failure therapy during the 3 months prior study inclusion (OMM). Stable is defined as no more than a 50% increase or 50% decrease in dose. If the patient is intolerant to full anti-heart failure medication, documented evidence must be available.
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- Patients who are able to perform a 6-minute walk test.
- Patients must have a body mass index within the range of 20 - 36 kg/m².
- Informed consent in writing from patient.
- Patients with an ICD systems can be included providing patients are not pacemaker dependent and the ICD system uses a single coil electrode the leads can be implanted in such a way that it is ensured, that the metal parts of the coil electrodes do not touch each other.
Who cannot join
- Patients who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Patients with an indication for a CRT system according to current guidelines.
- Patients who have been hospitalized for heart failure which required the use of inotropic support within 30 days before enrollment.
- Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.
- Patients with hemoglobin blood level < 12 g/dl in male and < 10 g/dl in female patients.
- Patients with primary pulmonary hypertension
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- Patients who have a genetic connective tissue disease (for example Marfan syndrome).
- Patients with constrictive pericarditis.
- Patients with a prosthetic tricuspid valve.
- Patients in whom access for implantation of the leads cannot be obtained (i.e., known venous occlusion, post radiation therapy).
- Patients who have other preexisting epicardial leads.
- Patients who have undergone prior heart surgery.
- Patient with other features (i.e., thorax deformity) that in the eyes of the investigator make the straightforward placement of the device seem unlikely.
- Patients with an ICD system who are pacemaker dependent
- Patients with an ICD system with a dual coil electrode.
- Patients with a CRT system or pacemaker.
- Patients with a CCM system.
- Current pregnancy or
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (e.g., intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator) 2 months before and until 1 month after C-MIC therapy.
- Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 2 months before screening.
- Breastfeeding/lactating women
- Patients whose exercise tolerance is limited by a condition other than heart failure (e.g., chronic obstructive pulmonary disease, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to participate in a 6-minute walk test.
- Patients on immunosuppressive therapy.
- Patients with present malignancy.
- Patients with an active infection considered by the investigator to be unsafe for the patient's participating in the trial.
- Patients with renal dysfunction (i.e., estimated glomerular filtration rate <45 mL/min / 1,73 m²)
- Patients with history or presence of relevant liver diseases or hepatic dysfunction as indicated by abnormal liver function tests at screening and baseline: ALT (SGPT), AST (SGOT), γ-GT, alkaline, phosphatase and serum bilirubin > 2 × upper limit of normal (ULN). Increase of these liver enzymes caused by cardiac disorders in the absence of other possible causes of liver damage are not are not meant by this.
- Patients with a history of drug or alcohol abuse within the 12 months prior to screening.
- Patients who, in the opinion of the Principal Investigator, are unlikely to comply with the protocol requirements, instructions and trial related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, psychological illness, and improbability of completing the trial.
- Participation in any study of an investigational device or drug within 90 days prior to planned study.
- Vulnerable Patients (e.g., patients requiring a legal representative, patients kept in detention, any service within the army, and employees of the sponsor or at an investigator site).
- Patients who are not able to avoid the following areas (i.e., due to work) such as areas with strong magnetic fields, areas with strong external electrical influences, areas with a warning notice "Access prohibited for pacemaker patients" or similar and areas with high temperatures.
Trial locations and contacts
20 sites in 11 countries.
20 sites in 11 countries
Germany5 sites
German Heart Center Charité
Berlin, 13353
Vivantes Humbold Clinic
Berlin, 13509
Heart Center Dresden
Dresden
Medical University Hannover
Hanover
University Hospital Regensburg
Regensburg
Serbia4 sites
Clinical Center of Serbia
Belgrade
Clinical Hospital Center Bezanijska Kosa
Belgrade
Institute of Cardiovascular Diseases Dedinje
Belgrade
Institute of Cardiovascular Diseases
Kamenitz, 21204
Bosnia and Herzegovina2 sites
University Clinic
Banja Luka, 78000
University Clinic Sarajevo
Sarajevo, 71000
Poland2 sites
Polish-American Heart Clinic
Bielsko-Biala, 43316
University Hospital Wroclaw
Wroclaw
About this study
Official title: Prospective, Randomized, Open, Comparison Study to Demonstrate the Performance and the Safety of Cardiac Microcurrent Therapy (C-MIC) System
Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according to treatment guidelines of heart failure and who have a baseline left ventricular ejection fraction of ≥25% and ≤35 will receive a C-MIC System and microcurrent therapy after device implantation with optimal medical management. At the end of the study after 6 months, the C-MIC System will be turned off. The control group will receive optimal medical management without device implantation.
Read the detailed description
Target patients for the C-MIC System are patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III - NYHA class IV) despite adequate therapy of heart failure and a left ventricular ejection fraction ranging from 25% to 35% with a history of heart failure of more than 1 year but less than 5 years.
The study's objective is to determine the safety and effectiveness of C-MIC therapy in patients with moderate to severe heart failure under optimal medical therapy. Data from a pilot study (C-MIC-I) indicate that an increase of ≥ 8% of the left ventricular ejection fraction can be achieved within a treatment period of 6 month. Therefore, the study hypothesis assumes hat the change in LVEF from baseline to 6 months will be significantly greater in patients undergoing C-MIC therapy (device group) in addition to guideline directed medical therapy (GDMT) compared patients remaining on GDMT alone (control group).
Subjects will be randomized in a 1:1 ratio to receive the C-MIC System in addition to optimal medical management or to receive optimal medical management alone without device. Due to the risks associated with the implantation, a sham (placebo) procedure is not warranted.
The primary endpoint will be measured as the difference in the change in LVEF from baseline to 6 months, measured via cardiac ultrasound and expressed in percentage. LVEF measurements will be compared between the device and control groups and verified by a core lab at baseline, week 4, month 4 and month 6.
- Conditions
- Systolic Left Ventricular Dysfunction
- Being tested
- CMIC, Standard of Care (SOC)
- 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.
CMICDevice
The C-MIC System consists of three implantable parts: a transvenous and an epicardial lead which are both connected to an implanted power source, and an external programing device. The patch lead is placed over the free wall of the left ventricle and fixated with sutures. When lead placement is achieved, the leads are then tunneled subcutaneously to the infraclavicular region and connected to the power source.
Standard of Care (SOC)Drug
Also called Standard drug therapy
Patients receive optimal SOC based defined in pertinent guideline and at the discretion of the investigator
| Study group | Role | What they receive |
|---|---|---|
| Device plus Standard of Care | Experimental | Device plus Standard of Care Receives: Device: CMIC; Drug: Standard of Care (SOC) |
| Standard of Care | Other | Standard of care drug treatment Receives: Drug: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Change of the left ventricular ejection fraction (LVEF) from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start5 Feb 2021
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berlin Heals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Goettel, MD, Study director, Berlin Heals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662034
- Sponsor's protocol ID
- CMIC-II
- Acronym
- C-MIC-II
- Status last verified
- Mar 2025
- First submitted
- 4 Dec 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rame JE, Schmitto JD, Kosevic DN, Kovacevic-Preradovic T, Jovev S, Zdravkovic M, Granov N, Popov T, Rudez I, Vukovic P, Ristic V, Neuzil P, Holtdirk A, Ruhparwar A, Khan MS, Dungen HD, Brandes K, Goettel P, Mueller J, Kallel F, Friede T, Peric M, Fudim M, Anker SD; C-MIC II Trial Investigators. Cardio-microcurrent device treatment for heart failure with reduced ejection fraction: Results from the C-MIC II open-label randomized controlled trial. Eur J Heart Fail. 2025 Oct;27(10):1837-1849. doi: 10.1002/ejhf.3763. Epub 2025 Jul 15.
PubMed 40660878
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open, Comparison Study to Demonstrate the Performance and the Safety of Cardiac Microcurrent Therapy (C-MIC) System
- ClinicalTrials.gov ID
- NCT04662034
- Acronym / sponsor ID
- C-MIC-II / CMIC-II
- Conditions
- Systolic Left Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Berlin Heals GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 10 Dec 2020 (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.
Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according to treatment guidelines of heart failure and who have a baseline left ventricular ejection fraction of ≥25% and ≤35 will receive a C-MIC System and microcurrent therapy after device implantation with optimal medical management. At the end of the study after 6 months, the C-MIC System will be turned off. The control group will receive optimal medical management without device implantation.
Detailed description
Target patients for the C-MIC System are patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III - NYHA class IV) despite adequate therapy of heart failure and a left ventricular ejection fraction ranging from 25% to 35% with a history of heart failure of more than 1 year but less than 5 years.
The study's objective is to determine the safety and effectiveness of C-MIC therapy in patients with moderate to severe heart failure under optimal medical therapy. Data from a pilot study (C-MIC-I) indicate that an increase of ≥ 8% of the left ventricular ejection fraction can be achieved within a treatment period of 6 month. Therefore, the study hypothesis assumes hat the change in LVEF from baseline to 6 months will be significantly greater in patients undergoing C-MIC therapy (device group) in addition to guideline directed medical therapy (GDMT) compared patients remaining on GDMT alone (control group).
Subjects will be randomized in a 1:1 ratio to receive the C-MIC System in addition to optimal medical management or to receive optimal medical management alone without device. Due to the risks associated with the implantation, a sham (placebo) procedure is not warranted.
The primary endpoint will be measured as the difference in the change in LVEF from baseline to 6 months, measured via cardiac ultrasound and expressed in percentage. LVEF measurements will be compared between the device and control groups and verified by a core lab at baseline, week 4, month 4 and month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device plus Standard of Care | Experimental | Device: CMIC, Drug: Standard of Care (SOC)Device plus Standard of Care |
| Standard of Care | Other | Drug: Standard of Care (SOC)Standard of care drug treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA III - IV (ambulatory)).
- Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening.
- Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by echocardiography within 30 days prior to study inclusion.
- Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic human study and about the intended treatment period of 6 months which is derived by the fact that according to current knowledge microcurrent treatment exceeding 6 months will not have additional favorable effects which means will not further improve cardiac function. Accordingly, battery life is limited. Furthermore, the patient is informed about the possibility for device explantation, informed regarding possible risks and is able to give written informed consent prior to any procedures and is considered willing and able to adhere to study regimen and to return for all follow-up visits.
- Patients are receiving guideline conform heart failure therapy
Key exclusion criteria (32 listed)
- Patients who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Patients with an indication for a CRT system according to current guidelines.
- Patients who have been hospitalized for heart failure which required the use of inotropic support within 30 days before enrollment.
- Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.
- Patients with hemoglobin blood level < 12 g/dl in male and < 10 g/dl in female 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 |
|---|---|---|
| CMICThe C-MIC System consists of three implantable parts: a transvenous and an epicardial lead which are both connected to an implanted power source, and an external programing device. The patch lead is placed over the free wall of the left ventricle and fixated with sutures. When lead placement is achieved, the leads are then tunneled subcutaneously to the infraclavicular region and connected to the power source. | Device | Device plus Standard of Care |
| Standard of Care (SOC)Also: Standard drug therapyPatients receive optimal SOC based defined in pertinent guideline and at the discretion of the investigator | Drug | Device plus Standard of Care, Standard of Care |
Primary outcome
Performance
Time frame: 6 months
Change of the left ventricular ejection fraction (LVEF) from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 40660878Rame JE, Schmitto JD, Kosevic DN, Kovacevic-Preradovic T, Jovev S, Zdravkovic M, Granov N, Popov T, Rudez I, Vukovic P, Ristic V, Neuzil P, Holtdirk A, Ruhparwar A, Khan MS, Dungen HD, Brandes K, Goettel P, Mueller J, Kallel F, Friede T, Peric M, Fudim M, Anker SD; C-MIC II Trial Investigators. Cardio-microcurrent device treatment for heart failure with reduced ejection fraction: Results from the C-MIC II open-label randomized controlled trial. Eur J Heart Fail. 2025 Oct;27(10):1837-1849. doi: 10.1002/ejhf.3763. Epub 2025 Jul 15.
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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. This study is not recruiting at the moment.
Peter Goettel, MD study director
Berlin Heals GmbH
20 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMIC in people with Systolic Left Ventricular Dysfunction, run by Berlin Heals GmbH at 20 sites in 11 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 10 inclusion and 32 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: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Serbia, Bosnia and Herzegovina, Poland, Bulgaria and 6 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662034, which also lists 1 linked publication.
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 6 Feb 2026.