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

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.

Study Overview

• Status: Recruiting
• Conditions: Systolic Left Ventricular Dysfunction
• Intervention / Treatment: Device: C-MIC system

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Goettel, MD; Phone Number: 61 +49 30 88913640; Email: goettel@berlinheals.de
• Study Contact Backup: Name: Kersten Brandes, MD; Phone Number: 66 +49 30 88913640; Email: brandes@berlinheals.de

Study Locations

• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Not yet recruiting
    • University Clinical Centre of Republic of Srpska
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Not yet recruiting
    • University Clinical Center of Sarajevo
• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • Clinical Hospital Dubrava
    • Contact: Igor Rudez, MD
• Serbia
  • Belgrade, Serbia
    • Recruiting
    • Clinical Center of Serbia
  • Belgrade, Serbia
    • Recruiting
    • Clinical Hospital Center Bezanijska Kosa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-MIC Device; Device plus Standard of Care	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Berlin Heals GmbH
• Investigators: Study Chair: Peter Goettel, MD, Berlin Heals GmbH

Publications and helpful links

Helpful Links

• Parent trial

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: C-MIC-II-FU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No