The C-MIC-II Follow-Up Study

Systolic Left Ventricular Dysfunction Clinical Trial

— C-MIC-II-FU  

Official title:

The C-MIC-II Follow-Up Study

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: March 2023
• Source: Berlin Heals GmbH
• Contact: Peter Goettel, MD
• Phone: +49 30 88913640
• Email: goettel[@]berlinheals.de
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Systolic Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

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
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,  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

External Links

•   Parent trial