Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT04662034
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2020-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance and Safety of the Cardiac Microcurrent Therapy System
Sponsor:
Berlin Heals GmbH
Organization:
Study Overview
Official Title:
Prospective, Randomized, Open, Comparison Study to Demonstrate the Performance and the Safety of Cardiac Microcurrent Therapy (C-MIC) System
Status:
COMPLETED
Status Verified Date:
2025-03
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
Brief Summary:
Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according to treatment guidelines of heart failure and who have a baseline left ventricular ejection fraction of ≥25% and ≤35 will receive a C-MIC System and microcurrent therapy after device implantation with optimal medical management. At the end of the study after 6 months, the C-MIC System will be turned off. The control group will receive optimal medical management without device implantation.
Detailed Description:
Target patients for the C-MIC System are patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III - NYHA class IV) despite adequate therapy of heart failure and a left ventricular ejection fraction ranging from 25% to 35% with a history of heart failure of more than 1 year but less than 5 years.
The study's objective is to determine the safety and effectiveness of C-MIC therapy in patients with moderate to severe heart failure under optimal medical therapy. Data from a pilot study (C-MIC-I) indicate that an increase of ≥ 8% of the left ventricular ejection fraction can be achieved within a treatment period of 6 month. Therefore, the study hypothesis assumes hat the change in LVEF from baseline to 6 months will be significantly greater in patients undergoing C-MIC therapy (device group) in addition to guideline directed medical therapy (GDMT) compared patients remaining on GDMT alone (control group).
Subjects will be randomized in a 1:1 ratio to receive the C-MIC System in addition to optimal medical management or to receive optimal medical management alone without device. Due to the risks associated with the implantation, a sham (placebo) procedure is not warranted.
The primary endpoint will be measured as the difference in the change in LVEF from baseline to 6 months, measured via cardiac ultrasound and expressed in percentage. LVEF measurements will be compared between the device and control groups and verified by a core lab at baseline, week 4, month 4 and month 6.
The study's objective is to determine the safety and effectiveness of C-MIC therapy in patients with moderate to severe heart failure under optimal medical therapy. Data from a pilot study (C-MIC-I) indicate that an increase of ≥ 8% of the left ventricular ejection fraction can be achieved within a treatment period of 6 month. Therefore, the study hypothesis assumes hat the change in LVEF from baseline to 6 months will be significantly greater in patients undergoing C-MIC therapy (device group) in addition to guideline directed medical therapy (GDMT) compared patients remaining on GDMT alone (control group).
Subjects will be randomized in a 1:1 ratio to receive the C-MIC System in addition to optimal medical management or to receive optimal medical management alone without device. Due to the risks associated with the implantation, a sham (placebo) procedure is not warranted.
The primary endpoint will be measured as the difference in the change in LVEF from baseline to 6 months, measured via cardiac ultrasound and expressed in percentage. LVEF measurements will be compared between the device and control groups and verified by a core lab at baseline, week 4, month 4 and month 6.
Study Oversight
Has Oversight DMC:
True
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?: