The C-MIC-II Follow-Up Study

NCT05189860 | Recruiting

• 1 other identifier: C-MIC-II-FU
• Study Type: interventional
• Target: 31
• Locations: 4 countries
• Sites: 6

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.

Conditions

Systolic Left Ventricular Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in cardiac performance

  2 Years

• Treatment adjustment

  2 Years

• Patient related outcome

  2 years

• Change in New York Heart Association (NYHA) classification

  2 years

• Cange in exercise ability

  2 years

Study Arms (1)

C-MIC Device

EXPERIMENTAL

Device plus Standard of Care

Device: C-MIC system

Interventions

C-MIC system DEVICE

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.

C-MIC Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have received a C-MIC System during the C-MIC-II Study.
• Informed consent in writing from the patient.

You may not qualify if:

• Patients who are unwilling or unable to participate in the study visits.
• Vulnerable Patients.

Sponsors & Collaborators

• Berlin Heals GmbH: lead

Study Sites (6)

University Clinical Centre of Republic of Srpska

Banja Luka, Banja Luka, 78000, Bosnia and Herzegovina

NOT YET RECRUITING

University Clinical Center of Sarajevo

Sarajevo, Sarajevo, 71000, Bosnia and Herzegovina

NOT YET RECRUITING

Clinical Hospital Dubrava

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

University Clinic Cardiac Surgery

Skopje, 1000, North Macedonia

RECRUITING

Clinical Center of Serbia

Belgrade, Serbia

RECRUITING

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

RECRUITING

Related Links

• Parent trial

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Peter Goettel, MD

  Berlin Heals GmbH

  STUDY CHAIR

Central Study Contacts

Peter Goettel, MD

CONTACT

+49 30 88913640; goettel@berlinheals.de

Kersten Brandes, MD

CONTACT

+49 30 88913640; brandes@berlinheals.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 13, 2022
• Study Start: March 3, 2022
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); NO (1); BO (2); CR (1)