The C-MIC-II Follow-Up Study

Not Applicable

Active, not recruiting

• Conditions: Systolic Left Ventricular Dysfunction
• Interventions: Device: C-MIC system

• Registration Number: NCT05189860
• Lead Sponsor: Berlin Heals GmbH

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-13
• Study Start: 2022-03-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 29

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-MIC Device	C-MIC system	Device plus Standard of Care

Primary Outcome Measures

Name	Time	Method
Mortality	2 years	Rate of all cause, cardiac and device related mortality
Hospitalizations	2 years	Rate of all-cause, cardiac and device related hospitalizations
Adverse events	2 years	Overall incidence and severity of adverse events including malfunction

Secondary Outcome Measures

Name	Time	Method
Cange in exercise ability	2 years	Cardiopulmonary exercise test
Patient related outcome	2 years	Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status
Change in New York Heart Association (NYHA) classification	2 years	NYHA functional class
Change in aerobic capacity and endurance	2 years	6 Minute walk test
Treatment adjustment	2 Years	Need for prolonged therapy with the C-MIC System in responder patients
Change in cardiac performance	2 Years	Left ventricular ejection fraction

Trial Locations

Locations (5)

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

University Clinical Center of Sarajevo; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Clinical Hospital Dubrava; 🇭🇷 Zagreb, Croatia

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Clinical Hospital Center Bezanijska Kosa; 🇷🇸 Belgrade, Serbia