Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
31 participants
INTERVENTIONAL
2022-03-03
2026-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Target patients for this study are patients who have received the device in a prior study.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Performance and Safety of the Cardiac Microcurrent Therapy System
NCT04662034
Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
NCT06920030
Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy
NCT02553785
MIBG Scintigraphy as a Tool for Selecting Patients Requiring Implantable Cardioverter Defibrillator (ICD)
NCT01185756
Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization
NCT05155865
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
C-MIC Device
Device plus Standard of Care
C-MIC system
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
C-MIC system
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent in writing from the patient.
Exclusion Criteria
* Vulnerable Patients.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Berlin Heals GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Goettel, MD
Role: STUDY_CHAIR
Berlin Heals GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Clinical Centre of Republic of Srpska
Banja Luka, Banja Luka, Bosnia and Herzegovina
University Clinical Center of Sarajevo
Sarajevo, Sarajevo, Bosnia and Herzegovina
Clinical Hospital Dubrava
Zagreb, City of Zagreb, Croatia
University Clinic Cardiac Surgery
Skopje, , North Macedonia
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Igor Rudez, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Parent trial
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C-MIC-II-FU
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.