Actively Recruiting
Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
Led by Berlin Heals GmbH · Updated on 2026-03-18
22
Participants Needed
4
Research Sites
103 weeks
Total Duration
On this page
Sponsors
B
Berlin Heals GmbH
Lead Sponsor
S
SCIRENT Clinical Research and Science d.o.o.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with idiopathic dilated cardiomyopathy and systolic left ventricular dysfunction (NYHA III-IV)
- Baseline left ventricular ejection fraction between 25% and 35% for idiopathic dilated cardiomyopathy patients
- Patients with non-ischemic cardiomyopathy and mildly reduced left ventricular ejection fraction (NYHA III-IV)
- Baseline left ventricular ejection fraction greater than 40% and less than 50% for non-ischemic cardiomyopathy patients
- Symptomatic chronic heart failure for more than 1 year and less than 5 years
- Female and male patients aged 18 to 75 years
- Patients who understand the procedure and agree to participate with informed consent
- Patients receiving stable guideline-directed medical therapy for heart failure for at least 3 months prior to screening
- Ability to perform a non-assisted 6-minute walk test
- Body mass index between 20 and 36 kg/m2
- Written informed consent obtained
You will not qualify if you...
- Patients with correctible causes of heart failure such as valvular or congenital heart disease
- Patients indicated for a cardiac resynchronization therapy (CRT) system
- Patients hospitalized for heart failure requiring inotropic support within 30 days before screening
- Patients with systolic blood pressure above 150 mmHg and diastolic above 90 mmHg despite treatment
- Male patients with hemoglobin below 12 g/dl, female patients below 10 g/dl
- Patients with primary pulmonary hypertension
- Patients with genetic connective tissue diseases (e.g., Marfan syndrome)
- Patients with a prosthetic tricuspid valve
- Patients without suitable access for device implantation
- Patients with thorax deformities that prevent device placement
- Patients with pacemaker, ICD, CRT, or CCM systems
- Current pregnancy or breastfeeding
- Women of childbearing potential not using effective contraception
- Patients with exercise limitations due to other conditions
- Patients on immunosuppressive therapy
- Patients with active malignancy or infection
- Patients with renal dysfunction (eGFR <45 mL/min/1.73 m2)
- Patients with abnormal liver function tests above twice the upper limit of normal not caused by cardiac disorders
- History of drug or alcohol abuse within 12 months
- Patients unlikely to comply with study requirements
- Participation in other investigational studies within 90 days
- Vulnerable patients such as those requiring legal representatives or in detention
- Patients unable to avoid exposure to strong magnetic fields, electrical influences, or high temperatures due to work
AI-Screening
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Trial Site Locations
Total: 4 locations
1
University Clinical Center of the Republic of Srbska
Banja Luka, Republic of Srbska, Bosnia and Herzegovina, 78000
Actively Recruiting
2
Institute of Cardiovascular Disease Dedinje
Belgrade, Serbia, 11040
Actively Recruiting
3
Clinical Hospital Center Bezanijska kosa
Belgrade, Serbia, 11080
Actively Recruiting
4
UKC Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
Research Team
S
Susanne Becker
CONTACT
J
John Brumfield
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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