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

Primary Purpose

Systolic Left Ventricular Dysfunction

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

C-MIC system

About this trial

This is an interventional treatment trial for Systolic Left Ventricular Dysfunction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University Clinical Centre of Republic of Srpska
University Clinical Center of Sarajevo
Clinical Center of SerbiaRecruiting
Clinical Hospital Center Bezanijska KosaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-MIC Device

Arm Description

Device plus Standard of Care

Outcomes

Primary Outcome Measures

Mortality

Rate of all cause, cardiac and device related mortality

Hospitalizations

Rate of all-cause, cardiac and device related hospitalizations

Adverse events

Overall incidence and severity of adverse events including malfunction

Secondary Outcome Measures

Change in cardiac performance

Left ventricular ejection fraction

Treatment adjustment

Need for prolonged therapy with the C-MIC System in responder patients

Patient related outcome

Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status

Change in New York Heart Association (NYHA) classification

NYHA functional class

Cange in exercise ability

Cardiopulmonary exercise test

Change in aerobic capacity and endurance

6 Minute walk test

Full Information

NCT ID

NCT05189860

First Posted

December 27, 2021

Last Updated

March 21, 2023

Sponsor

Berlin Heals GmbH

1. Study Identification

Unique Protocol Identification Number

NCT05189860

Brief Title

The C-MIC-II Follow-Up Study

Acronym

C-MIC-II-FU

Official Title

The C-MIC-II Follow-Up Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 3, 2022 (Actual)

Primary Completion Date

June 15, 2025 (Anticipated)

Study Completion Date

June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Berlin Heals GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systolic Left Ventricular Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

C-MIC Device

Arm Type

Experimental

Arm Description

Device plus Standard of Care

Intervention Type

Device

Intervention Name(s)

C-MIC system

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mortality

Description

Rate of all cause, cardiac and device related mortality

Time Frame

2 years

Title

Hospitalizations

Description

Rate of all-cause, cardiac and device related hospitalizations

Time Frame

2 years

Title

Adverse events

Description

Overall incidence and severity of adverse events including malfunction

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Change in cardiac performance

Description

Left ventricular ejection fraction

Time Frame

2 Years

Title

Treatment adjustment

Description

Need for prolonged therapy with the C-MIC System in responder patients

Time Frame

2 Years

Title

Patient related outcome

Description

Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status

Time Frame

2 years

Title

Change in New York Heart Association (NYHA) classification

Description

NYHA functional class

Time Frame

2 years

Title

Cange in exercise ability

Description

Cardiopulmonary exercise test

Time Frame

2 years

Title

Change in aerobic capacity and endurance

Description

6 Minute walk test

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Goettel, MD

Phone

+49 30 88913640

Ext

goettel@berlinheals.de

First Name & Middle Initial & Last Name or Official Title & Degree

Kersten Brandes, MD

Phone

+49 30 88913640

Ext

brandes@berlinheals.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Goettel, MD

Organizational Affiliation

Berlin Heals GmbH

Official's Role

Study Chair

Facility Information:

Facility Name

University Clinical Centre of Republic of Srpska

City

Banja Luka

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Individual Site Status

Not yet recruiting

Facility Name

University Clinical Center of Sarajevo

City

Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Individual Site Status

Not yet recruiting

Facility Name

Clinical Center of Serbia

City

Belgrade

Country

Serbia

Individual Site Status

Recruiting

Facility Name

Clinical Hospital Center Bezanijska Kosa

City

Belgrade

Country

Serbia

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://clinicaltrials.gov/ct2/show/NCT04662034

Description

Parent trial

Learn more about this trial

The C-MIC-II Follow-Up Study

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