Actively Recruiting
Pilot Study to Investigate the Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasive Left Ventricular Lead Placement
Led by Berlin Heals GmbH · Updated on 2026-03-18
22
Participants Needed
4
Research Sites
N/A
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
This research aims to evaluate the Cardiac Microcurrent (C-MIC) System in patients with idiopathic dilated cardiomyopathy or non-ischemic cardiomyopathy who have heart failure classified as NYHA III-IV. Participants have specific ranges of left ventricular ejection fraction despite receiving guideline-directed medical therapy. The study focuses on patients with a documented history of heart failure lasting more than one year but less than five years. The goal is to assess changes in heart function after treatment with the C-MIC device. The C-MIC System involves implanting a device that delivers a weak direct microcurrent to the heart through a less invasive procedure that does not require open-heart surgery. Participants are assigned to one of two groups based on their condition, with the left ventricular patch electrode placed using this less invasive method. Treatment lasts for six months, after which the device's microcurrent is turned off. The primary goal is to measure the change in left ventricular ejection fraction after six months of treatment. During the study, participants will undergo evaluations to measure heart function, including left ventricular ejection fraction at baseline and after six months. They will also be monitored for their ability to perform a six-minute walk test and adherence to stable heart failure therapy before and during the study. Researchers will track heart function improvements and safety throughout the treatment period. The total participation time includes the six months of device therapy and follow-up assessments.
CONDITIONS
Brief 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...
- Adults aged 18 to 75 years
- Diagnosed idiopathic dilated cardiomyopathy with systolic left ventricular dysfunction (NYHA class III-IV) and left ventricular ejection fraction between 25% and 35%
- Diagnosed non-ischemic cardiomyopathy with systolic left ventricular dysfunction (NYHA class III-IV) and left ventricular ejection fraction between 41% and 49%
- Symptomatic chronic heart failure for more than 1 year but less than 5 years
- Understands the procedure and ongoing device therapy and can provide written informed consent
- Receiving stable guideline-directed medical therapy for heart failure for at least 3 months prior to screening
- Able to perform a non-assisted 6-minute walk test
- Body mass index between 20 and 36 kg/m²
You will not qualify if you...
- Correctible causes of heart failure such as valvular or congenital heart disease
- Indication for a cardiac resynchronization therapy (CRT) system
- Hospitalization for heart failure requiring inotropic support within 30 days prior to screening
- Systolic blood pressure above 150 mmHg or diastolic above 90 mmHg despite optimal treatment
- Low hemoglobin levels (<12 g/dl in males, <10 g/dl in females)
- Primary pulmonary hypertension
- Genetic connective tissue diseases like Marfan syndrome
- Prosthetic tricuspid valve
- Inability to access implantation site due to venous occlusion or prior radiation
- Thorax deformities or other conditions making device placement unlikely
- Presence of pacemaker, ICD, CRT, or CCM systems
- Current pregnancy or breastfeeding
- Women of childbearing potential not using effective contraception
- Exercise intolerance due to other conditions such as COPD or peripheral vascular disease
- Immunosuppressive therapy
- Active malignancy
- Active infection unsafe for study participation
- Renal dysfunction with eGFR below 45 mL/min/1.73 m²
- Significant liver disease or abnormal liver function tests
- History of drug or alcohol abuse within 12 months
- Unlikely to comply with study requirements
- Participation in another investigational study within 90 days
- Vulnerable patients requiring legal representatives or detained
- Inability to avoid strong magnetic or electrical fields or high-temperature areas due to work
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive implantation of the cardiac microcurrent device using a less invasive technique for the left ventricular lead placement.
1 implantation visit (in-person)
Duration - 6 months
Participants undergo ongoing microcurrent therapy delivered by the implanted device to improve heart function.
Regular follow-up visits during treatment
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
J
John Brumfield
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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