The C-MIC-II Follow-Up Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBerlin Heals GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have received a C-MIC System during the C-MIC-II Study.
Informed consent in writing from the patient.
Disqualifiers
Patients who are unwilling or unable to participate in the study visits.
Vulnerable Patients.
Trial design
Design model
Single group
Treatments tested in this trial
C-MIC system
DeviceThis 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.
Treatment groups
31 Participants
are divided into 1 treatment groupGroup A: C-MIC DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mortality
Rate of all cause, cardiac and device related mortality
Time frame
2 years2
Hospitalizations
Rate of all-cause, cardiac and device related hospitalizations
Time frame
2 years3
Adverse events
Overall incidence and severity of adverse events including malfunction
Time frame
2 yearsSecondary outcomes
1
Change in cardiac performance
Left ventricular ejection fraction
Time frame
2 Years2
Treatment adjustment
Need for prolonged therapy with the C-MIC System in responder patients
Time frame
2 Years3
Patient related outcome
Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status
Time frame
2 years4
Change in New York Heart Association (NYHA) classification
NYHA functional class
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov