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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05189860
Other study ID # C-MIC-II-FU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2022
Est. completion date June 15, 2025

Study information

Verified date April 2024
Source Berlin Heals GmbH
Contact Peter Goettel, MD
Phone +49 30 88913640
Email goettel@berlinheals.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart. Target patients for this study are patients who have received the device in a prior study.


Description:

The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart. The therapy with the C-MIC System is intended to take 6 months. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 15, 2025
Est. primary completion date June 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients who have received a C-MIC System during the C-MIC-II Study. - Informed consent in writing from the patient. Exclusion Criteria: - Patients who are unwilling or unable to participate in the study visits. - Vulnerable Patients.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Bosnia and Herzegovina University Clinical Centre of Republic of Srpska Banja Luka
Bosnia and Herzegovina University Clinical Center of Sarajevo Sarajevo
Croatia Clinical Hospital Dubrava Zagreb
Serbia Clinical Center of Serbia Belgrade
Serbia Clinical Hospital Center Bezanijska Kosa Belgrade

Sponsors (1)

Lead Sponsor Collaborator
Berlin Heals GmbH

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Croatia,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Rate of all cause, cardiac and device related mortality 2 years
Primary Hospitalizations Rate of all-cause, cardiac and device related hospitalizations 2 years
Primary Adverse events Overall incidence and severity of adverse events including malfunction 2 years
Secondary Change in cardiac performance Left ventricular ejection fraction 2 Years
Secondary Treatment adjustment Need for prolonged therapy with the C-MIC System in responder patients 2 Years
Secondary Patient related outcome Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status 2 years
Secondary Change in New York Heart Association (NYHA) classification NYHA functional class 2 years
Secondary Cange in exercise ability Cardiopulmonary exercise test 2 years
Secondary Change in aerobic capacity and endurance 6 Minute walk test 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT04662034 - Performance and Safety of the Cardiac Microcurrent Therapy System N/A

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