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NCT Number: NCT05189860

The C-MIC-II Follow-Up Study

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.

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Key information

Conditions

Systolic Left Ventricular Dysfunction Cardiovascular Diseases Heart Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Centre of Republic of Srpska, Banja Luka, Bosnia and Herzegovina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

C-MIC system

Device

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.

Primary outcomes

  1. Mortality

    Time frame: 2 years

    Rate of all cause, cardiac and device related mortality

  2. Hospitalizations

    Time frame: 2 years

    Rate of all-cause, cardiac and device related hospitalizations

  3. Adverse events

    Time frame: 2 years

    Overall incidence and severity of adverse events including malfunction

Secondary outcomes

  1. Change in cardiac performance

    Time frame: 2 Years

    Left ventricular ejection fraction

  2. Treatment adjustment

    Time frame: 2 Years

    Need for prolonged therapy with the C-MIC System in responder patients

  3. Patient related outcome

    Time frame: 2 years

    Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status

  4. Change in New York Heart Association (NYHA) classification

    Time frame: 2 years

    NYHA functional class

  5. Cange in exercise ability

    Time frame: 2 years

    Cardiopulmonary exercise test

  6. Change in aerobic capacity and endurance

    Time frame: 2 years

    6 Minute walk test

Study contacts

Contact information is provided by the study sponsor or research team.

Kersten Brandes, MD

CONTACT

[email protected]

+49 30 88913640 ext. 66

Peter Goettel, MD

CONTACT

[email protected]

+49 30 88913640 ext. 61

Sponsors and collaborators

Lead sponsor

Berlin Heals GmbH

Industry

Registry information

Acronym: C-MIC-II-FU

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2022
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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