Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-31 @ 10:23 PM
Study NCT ID:
NCT05189860
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The C-MIC-II Follow-Up Study
Sponsor:
Berlin Heals GmbH
Organization:
Study Overview
Official Title:
The C-MIC-II Follow-Up Study
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C-MIC-II-FU
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: