The C-MIC-II Follow-Up Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The C-MIC-II Follow-Up Study

Conditions
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Systolic Left Ventricular Dysfunction

Intervention / Treatment
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* Device: C-MIC system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Study objective is to assess the safety of the C-MIC System in case of system extended use or abandonment or explantation in patients having received a C-MIC System in the context of a prior study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-MIC Device<br>Device plus Standard of Care | Device: C-MIC system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Rate of all cause, cardiac and device related mortality | 2 years | 
| Hospitalizations | Rate of all-cause, cardiac and device related hospitalizations | 2 years | 
| Adverse events | Overall incidence and severity of adverse events including malfunction | 2 years | 

Secondary Outcome Measures

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