DRKS00015708已完成1 期
First-In-Human Pilot Study to Demonstrate the Safety and the Performance of the Cardiac Microcurrent Therapy System (CMIC System) - SPOT C-MIC-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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