I50.9
Conditions
Interventions
Group 1: Implantation of the C-MIC - System
Sponsors
Berlin Heals GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients who have systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA III) • Female and male patients aged =18 years • Patient who understands the nature of the procedure and on-going device therapy. • Patients with symptomatic chronic heart failure without relevant comorbidities and reduced ejection fraction caused by idiopathic, dilative, non-ischemic cardiomyopathy or inflammatory or hypertrophic non-obstructive cardiomyopathy for less than 5 years at screening. • Patients who have a baseline ejection fraction of > 25% and < 40% assessed by echocardiography within 15-30 days prior to study inclusion • Patients receiving appropriate, stable guideline conform anti-heart failure therapy during the 30 days before study inclusion • Patients who are able to perform a 6-minute walk test. • Patients must have a body mass index within the range of 20 - 36 kg/m² • Informed consent in writing from patient
Exclusion criteria
Exclusion criteria: • Patients who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease • Patients with a prosthetic tricuspid valve • Patients who have undergone prior heart surgery • Patients who have a constrictive pericarditis • Patients who have a primary pulmonary hypertension • Patients with heart failure due to coronary artery disease • Patients who have a genetic connective tissue disease (for example Marfan syndrome) • Patients who have a heart disease not in consequence of a chronic inflammatory processes • Patients with heart failure with preserved ejection function • Patients who have a history of cardiac insufficiency > 5 years prior to implantation of the C-MIC system • Patients who have a cardiac implantable electronic device i.e. pacemaker, defibrillator, etc. • Patients who have been hospitalized for heart failure which required the use of inotropic support within 30 days before enrollment. • Patients whose exercise tolerance is limited by a condition other than heart failure or who are unable to participate in a 6-minute walk or a cardiopulmonary stress test. • Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment. • Patients with renal dysfunction • Patients with history or presence of relevant liver diseases or hepatic dysfunction as indicated by abnormal liver function tests at screening and baseline • Patients with hemoglobin blood level < 12 g/dl in male and < 10 g/dl in female patients • Active infection considered by the investigator to be unsafe for the patient’s participating in the trial • Patients on immunosuppressive therapy • Participation in any study of an investigational device or drug within 90 days prior to planned study • Present malignancy • Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception • Patients with a history of drug or alcohol abuse within the 12 months prior to screening. • Patients who, in the opinion of the Principle Investigator, are unlikely to comply with the protocol requirements, instructions and trial related restrictions • Patient is directly involved in the conduct of the trial • Vulnerable Patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the preliminary safety of "Cardiac Microcurrent Therapy" in the requested population. To assess safety, all adverse events are recorded during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the preliminary effectiveness of "Cardiac Microcurrent Therapy" in the requested population. Effectiveness is assessed by patient performance (measured by shortness of breath and 6-minutes walking distance), quality of life (measured by questionnaire), cardiac function (measured by cardiac ultrasound), and laboratory results. | — |
Countries
Austria, Serbia
Contacts
Public ContactDominik Wiedemann
Department of Cardiac SurgeryMedical University of Vienna
Outcome results
None listed