First-In-Human Pilot Study to Demonstrate the Safety and the Performance of the Cardiac Microcurrent Therapy System (CMIC System)
- Conditions
- I50.9Heart failure, unspecified
- Registration Number
- DRKS00015708
- Lead Sponsor
- Berlin Heals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
• 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
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.