Performance and Safety of the Cardiac Microcurrent Therapy System

Exclusion Criteria

• •Patients who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
• •Patients with an indication for a CRT system according to current guidelines.
• •Patients who have been hospitalized for heart failure which required the use of inotropic support within 30 days before enrollment.
• •Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.
• •Patients with hemoglobin blood level \< 12 g/dl in male and \< 10 g/dl in female patients.
• •Patients with primary pulmonary hypertension
• •Patients who have a genetic connective tissue disease (for example Marfan syndrome).
• •Patients with constrictive pericarditis.
• •Patients with a prosthetic tricuspid valve.
• •Patients in whom access for implantation of the leads cannot be obtained (i.e., known venous occlusion, post radiation therapy).
• •Patients who have other preexisting epicardial leads.
• •Patients who have undergone prior heart surgery.
• •Patient with other features (i.e., thorax deformity) that in the eyes of the investigator make the straightforward placement of the device seem unlikely.
• •Patients with an ICD system who are pacemaker dependent
• •Patients with an ICD system with a dual coil electrode.
• •Patients with a CRT system or pacemaker.
• •Patients with a CCM system.
• •Current pregnancy or
• •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (e.g., intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator) 2 months before and until 1 month after C-MIC therapy.
• •Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 2 months before screening.
• •Breastfeeding/lactating women
• •Patients whose exercise tolerance is limited by a condition other than heart failure (e.g., chronic obstructive pulmonary disease, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to participate in a 6-minute walk test.
• •Patients on immunosuppressive therapy.
• •Patients with present malignancy.
• •Patients with an active infection considered by the investigator to be unsafe for the patient's participating in the trial.
• •Patients with renal dysfunction (i.e., estimated glomerular filtration rate \<45 mL/min / 1,73 m²)
• •Patients with history or presence of relevant liver diseases or hepatic dysfunction as indicated by abnormal liver function tests at screening and baseline: ALT (SGPT), AST (SGOT), γ-GT, alkaline, phosphatase and serum bilirubin \> 2 × upper limit of normal (ULN). Increase of these liver enzymes caused by cardiac disorders in the absence of other possible causes of liver damage are not are not meant by this.
• •Patients with a history of drug or alcohol abuse within the 12 months prior to screening.
• •Patients who, in the opinion of the Principal Investigator, are unlikely to comply with the protocol requirements, instructions and trial related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, psychological illness, and improbability of completing the trial.
• •Participation in any study of an investigational device or drug within 90 days prior to planned study.
• •Vulnerable Patients (e.g., patients requiring a legal representative, patients kept in detention, any service within the army, and employees of the sponsor or at an investigator site).
• •Patients who are not able to avoid the following areas (i.e., due to work) such as areas with strong magnetic fields, areas with strong external electrical influences, areas with a warning notice "Access prohibited for pacemaker patients" or similar and areas with high temperatures.