The C-MIC-II Follow-Up Study | NCT05189860

Studies
The C-MIC-II Follow-Up Study

NCT05189860

Sponsor

Berlin Heals GmbH

Status

Recruiting

Last Update Posted

Jun 8, 2025Actual

Enrollment

31Estimated

Phase

Not Applicable

Conditions

Systolic Left Ventricular Dysfunction

Interventions

C-MIC system

Countries

Bosnia and Herzegovina
Croatia
North Macedonia
Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2022Actual

Primary Completion Date

Nov 15, 2026Estimated

Completion Date

Nov 15, 2026Estimated

First Submitted Date

Dec 27, 2021

First Submission Date that Met QC Criteria

Jan 12, 2022

First Posted Date

Jan 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2025

Last Update Posted Date

Jun 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C-MIC Device	Experimental	Device plus Standard of Care	Device: C-MIC system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Goettel, MD	Contact	+49 30 88913640	61	goettel@berlinheals.de
Kersten Brandes, MD	Contact	+49 30 88913640	66	brandes@berlinheals.de

Overall Officials

Name	Affiliation	Role
Peter Goettel, MD	Berlin Heals GmbH	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinical Centre of Republic of Srpska	Not yet recruiting	Banja Luka	Banja Luka	78000	Bosnia and Herzegovina

Label	URL
Parent trial	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018487	Ventricular Dysfunction, Left

Ancestor Terms

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.