Clinical trial NCT05189860: The C-MIC-II Follow-Up Study
Official title: The C-MIC-II Follow-Up Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systolic Left Ventricular Dysfunction
Lead sponsor: Berlin Heals GmbH
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: 2 years
measure: Hospitalizations
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Change in cardiac performance
timeFrame: 2 Years
measure: Treatment adjustment
timeFrame: 2 Years
measure: Patient related outcome
timeFrame: 2 years
measure: Change in New York Heart Association (NYHA) classification
timeFrame: 2 years
measure: Cange in exercise ability
timeFrame: 2 years
measure: Change in aerobic capacity and endurance
timeFrame: 2 years
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Center of Sarajevo
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Skopje
country: North Macedonia
facility: University Clinic Cardiac Surgery
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
Study officials:
affiliation: Berlin Heals GmbH
name: Peter Goettel, MD
role: STUDY_CHAIR
References: