The C-MIC-II Follow-Up Study (C-MIC-II-FU)

Berlin Heals

Status: Active, not recruiting

Conditions: Systolic Left Ventricular Dysfunction

Treatments: Device: C-MIC system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05189860

C-MIC-II-FU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

C-MIC Device

Experimental group

Description:

Device plus Standard of Care

Treatment:

Device: C-MIC system