Idiopathic CardiomyopathyNCT06920030
Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
A study testing Subcutaneous cardiac microcurrent treatment in people with Idiopathic Cardiomyopathy and Left Ventricular (LV) Systolic Dysfunction, run by Berlin Heals GmbH at 4 sites in 2 countries.
Trial summary
Patients with idiopathic dilated cardiomyopathy in heart failure (NYHA class III - IV) with a baseline left ventricular ejection fraction between ≥25% and ≤35%, and patients with non-ischemic cardiomyopathy in heart failure (NYHA class III-IV) with a baseline left ventricular ejection fraction >40% and <50% despite… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction, Non-ischemic Cardiomyopathy
- What is being tested?
- Subcutaneous cardiac microcurrent treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Apr 2025to Apr 2027
- 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 with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening based on the date of diagnosis.
- Female and male patients aged ≥18 years - 75 years.
- Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic clinical trial 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 it will not further improve cardiac function. Furthermore, the patient is informed about the possibility of 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 the study regimen and to return for all follow-up visits.
- Patients receiving appropriate, stable guideline directed medical therapy for heart failure at least for the 3 months prior to screening. Stable is defined as no more than a 50% increase or 50% decrease in dose. If the patient is intolerant of guideline recommended doses of heart failure medication, documented evidence must be available.
- Guideline directed medical therapy includes for:
- Patients with HFrEF:
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- Angiotensin-converting enzyme inhibitor (ACE-I) or
- Angiotensin receptor-neprilysin inhibitor (ARNI)
- Beta-blocker
- Mineralocorticoid receptor antagonist (MRA)
- Dapagliflozin/Empagliflozin inhibitor (SGLT2i)
- Patients with HFmrEF - Diuretics (if symptomatic)
- Dapagliflozin/Empagliflozin inhibitor (SGLT2i)
- Patients who can perform a non-assisted 6-minute walk test.
- Patients must have a body mass index within the range of 20 - 36 kg/m².
- Informed consent in writing obtained from patient.
Who cannot join
- Patients who are not likely to experience improvement of their chronic heart failure by the microcurrent therapy, because the causes of the disease cannot be influenced even if the patients fulfill the indication for use of the device or if the therapy with the C-MIC System is not possible or might be associated with unknown risks:
- 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 screening.
- 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.
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- Patients with primary pulmonary hypertension
- Patients who have genetic connective tissue disease (for example Marfan syndrome).
- 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).
- 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 a pacemaker, an ICD system, a CRT system or with a CCM system.
- Current pregnancy or
- Breastfeeding/lactating women
- 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.
- Patients whose exercise tolerance is limited by a condition other than heart failure (e.g. chronic obstructive pulmonary disease, peripheral vascular 16.
- Patients on immunosuppressive therapy. 17.Patie nts with present malignancy. 18. Patients with an active infection considered by the investigator to be unsafe for the patient's participation in the study.
- 19. Patients with renal dysfunction (i.e., estimated glomerular filtration rate <45 mL/min /1,73 m²). Use the "CKD-EPI Creatinine Equation (2021)" as found on https://www.kidney.org/professionals/gfrcalculator.
- 20. 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 meant by this.
- 21. Patients with a history of drug or alcohol abuse within the 12 months prior to screening.
- 22. 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.
- 23. Participation in any study of an investigational device or drug within 90 days prior to planned study.
- 24. 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).
- 25. Patients who are not able to avoid the following areas (i.e. due to work):
- Areas with strong magnetic fields
- Areas with strong external electrical influences
- Areas with a warning notice "Access prohibited for pacemaker patients" or similar.
- Areas with high temperatures
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Serbia3 sites, 3 recruiting
- Recruiting
Institute of Cardiovascular Disease Dedinje
Belgrade, 11040
Dragana Kosevic, MD
Dragana Kosevic, MD
- Recruiting
Clinical Hospital Center Bezanijska kosa
Belgrade, 11080
- Recruiting
UKC Kragujevac
Kragujevac, 34000
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
University Clinical Center of the Republic of Srbska
Banja Luka, Republic of Srbska, 78000
About this study
Official title: Pilot Study to Investigate the Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
Patients with idiopathic dilated cardiomyopathy in heart failure (NYHA class III - IV) with a baseline left ventricular ejection fraction between ≥25% and ≤35%, and patients with non-ischemic cardiomyopathy in heart failure (NYHA class III-IV) with a baseline left ventricular ejection fraction >40% and <50% despite guideline-directed medical therapy, will receive C-MIC treatment in addition to optimal medical management.
The device can be implanted without the need for open-heart surgery. Patients are assigned to one of two groups according to the indications under investigation. At the end of the study after 6 months, the C-MIC System will be turned off. The primary endpoint of the study is the absolute change in left ventricular ejection fraction after 6 months of treatment.
Read the detailed description
Target patients for the C-MIC System include: (1) patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III-IV) despite adequate heart failure therapy and a left ventricular ejection fraction between 25% and 35%, and (2) patients with non-ischemic cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III-IV) despite adequate heart failure therapy and a left ventricular ejection fraction >40% and <50%. All patients must have a documented history of heart failure for more than 1 year but less than 5 years.
In previous studies, C-MIC was successfully implanted with one of the electrodes (the LV patch electrode) being placed directly on the heart. This study uses a less invasive technique to place the LV patch electrode, eliminating the need for a thoracotomy.
In all the groups, the effect of the microcurrent therapy will be assessed by comparing LV ejection fraction changes between baseline and after 6 months of microcurrent treatment (primary endpoint).
- Conditions
- Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction, Non-ischemic Cardiomyopathy
- Being tested
- Subcutaneous cardiac microcurrent treatment
- Keywords
- dilated cardiomyopathy, heart failure, non-ischemic cardiomyopathy
- Medical subject headings
- Cardiomyopathies, Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous cardiac microcurrent treatmentDevice
An implantable device that emits a weak direct (DC)-microcurrent directly to the heart.
Subcutaneous cardiac microcurrent treatmentDevice
An implantable device that emits a weak direct (DC)-microcurrent directly to the heart.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Sub-Q implantation | Experimental | The LV patch lead will be implanted in a less invasive way in patients with idiopathic dilated cardiomyopathy. Receives: Device: Subcutaneous cardiac microcurrent treatment |
| Group 2: Sub-Q implantation | Experimental | The LV patch lead will be implanted in a less invasive way in patients with idiopathic dilated cardiomyopathy and in patients with non-ischemic cardiomyopathy. Receives: Device: Subcutaneous cardiac microcurrent treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF) change from baseline
Absolute change of the left ventricular ejection fraction (LVEF) from baseline to 6 months as measured by echocardiography with Corelab. The changes from baseline will be analyzed by using the Mixed Model for Repeated Measures (MMRM), with the baseline value as covariate.
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 posted9 Apr 2025
- Study start9 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic CardiomyopathyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The CMIC-device effect was investigated in previous clinical studies. However, placement of the Left Ventricular Patch Lead up to now requires invasive surgery. This study shall investigate a procedure with less invasive placement of the LV patch lead.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berlin Heals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCIRENT Clinical Research and Science d.o.o.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920030
- Sponsor's protocol ID
- C-MIC-III
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2025
- Last updated
- 11 Aug 2026
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
- ClinicalTrials.gov ID
- NCT06920030
- Acronym / sponsor ID
- C-MIC-III
- Conditions
- Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction, Non-ischemic Cardiomyopathy
- Keywords
- dilated cardiomyopathy, heart failure, non-ischemic cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Berlin Heals GmbHIndustry (pharma, biotech, devices)
- Collaborators
- SCIRENT Clinical Research and Science d.o.o.
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Apr 2025 (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 dilated cardiomyopathy in heart failure (NYHA class III - IV) with a baseline left ventricular ejection fraction between ≥25% and ≤35%, and patients with non-ischemic cardiomyopathy in heart failure (NYHA class III-IV) with a baseline left ventricular ejection fraction >40% and <50% despite guideline-directed medical therapy, will receive C-MIC treatment in addition to optimal medical management.
The device can be implanted without the need for open-heart surgery. Patients are assigned to one of two groups according to the indications under investigation. At the end of the study after 6 months, the C-MIC System will be turned off. The primary endpoint of the study is the absolute change in left ventricular ejection fraction after 6 months of treatment.
Detailed description
Target patients for the C-MIC System include: (1) patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III-IV) despite adequate heart failure therapy and a left ventricular ejection fraction between 25% and 35%, and (2) patients with non-ischemic cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III-IV) despite adequate heart failure therapy and a left ventricular ejection fraction >40% and <50%. All patients must have a documented history of heart failure for more than 1 year but less than 5 years.
In previous studies, C-MIC was successfully implanted with one of the electrodes (the LV patch electrode) being placed directly on the heart. This study uses a less invasive technique to place the LV patch electrode, eliminating the need for a thoracotomy.
In all the groups, the effect of the microcurrent therapy will be assessed by comparing LV ejection fraction changes between baseline and after 6 months of microcurrent treatment (primary endpoint).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The CMIC-device effect was investigated in previous clinical studies. However, placement of the Left Ventricular Patch Lead up to now requires invasive surgery. This study shall investigate a procedure with less invasive placement of the LV patch lead.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Sub-Q implantation | Experimental | Device: Subcutaneous cardiac microcurrent treatmentThe LV patch lead will be implanted in a less invasive way in patients with idiopathic dilated cardiomyopathy. |
| Group 2: Sub-Q implantation | Experimental | Device: Subcutaneous cardiac microcurrent treatmentThe LV patch lead will be implanted in a less invasive way in patients with idiopathic dilated cardiomyopathy and in patients with non-ischemic cardiomyopathy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening based on the date of diagnosis.
- Female and male patients aged ≥18 years - 75 years.
- Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic clinical trial 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 it will not further improve cardiac function. Furthermore, the patient is informed about the possibility of 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 the study regimen and to return for all follow-up visits.
- Patients receiving appropriate, stable guideline directed medical therapy for heart failure at least for the 3 months prior to screening. Stable is defined as no more than a 50% increase or 50% decrease in dose. If the patient is intolerant of guideline recommended doses of heart failure medication, documented evidence must be available.
- Patients who can perform a non-assisted 6-minute walk test.
Key exclusion criteria (29 listed)
- Patients who are not likely to experience improvement of their chronic heart failure by the microcurrent therapy, because the causes of the disease cannot be influenced even if the patients fulfill the indication for use of the device or if the therapy with the C-MIC System is not possible or might be associated with unknown risks:
- 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 screening.
- Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.
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 |
|---|---|---|
| Subcutaneous cardiac microcurrent treatmentAn implantable device that emits a weak direct (DC)-microcurrent directly to the heart. | Device | Group 1: Sub-Q implantation |
| Subcutaneous cardiac microcurrent treatmentAn implantable device that emits a weak direct (DC)-microcurrent directly to the heart. | Device | Group 2: Sub-Q implantation |
Primary outcome
Left ventricular ejection fraction (LVEF) change from baseline
Time frame: 6 months
Absolute change of the left ventricular ejection fraction (LVEF) from baseline to 6 months as measured by echocardiography with Corelab. The changes from baseline will be analyzed by using the Mixed Model for Repeated Measures (MMRM), with the baseline value as covariate.
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 11 Aug 2026.
- 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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous cardiac microcurrent treatment in people with Idiopathic Cardiomyopathy and Left Ventricular (LV) Systolic Dysfunction, run by Berlin Heals GmbH at 4 sites in 2 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 16 inclusion and 29 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Serbia, Bosnia and Herzegovina. 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 Gill Glennon (+44 7786 377667, glennon@berlinheals.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) change from baseline (time frame: 6 months). 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 11 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.