[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-cardiomyopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-cardiomyopathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100586795","performance-of-the-cardiac-microcurrent-c-mic-system-with-a-less-invasively-placed-left-ventricular-lead-100586795",false,"NCT06920030","Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead","Pilot Study to Investigate the Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead","Inclusion Criteria Idiopathic Dilated Cardiomyopathy with HFrEF:\n\n1. Patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction despite adequate therapy of heart failure (NYHA III - IV).\n2. Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by corelab.\n\nInclusion Criteria Non-Ischaemic Cardiomyopathy with HFmrEF:\n\n1. Patients with non-ischemic cardiomyopathy with mildly reduced left ventricular ejection fraction despite adequate therapy of heart failure (NYHA III - IV).\n2. Patients who have a baseline left ventricular ejection fraction of \\>40% and \\\u003C50% assessed by corelab.\n\n   Inclusion Criteria for all Patients:\n3. Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening based on the date of diagnosis.\n4. Female and male patients aged ≥18 years - 75 years.\n5. Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic clinical trial and about the intended treatment period of 6 months which is derived by the fact that according to current knowledge microcurrent treatment exceeding 6 months will not have additional favorable effects which means it will not further improve cardiac function. Furthermore, the patient is informed about the possibility of device explantation, informed regarding possible risks and is able to give written informed consent prior to any procedures and is considered willing and able to adhere to the study regimen and to return for all follow-up visits.\n6. Patients receiving appropriate, stable guideline directed medical therapy for heart failure at least for the 3 months prior to screening. Stable is defined as no more than a 50% increase or 50% decrease in dose. If the patient is intolerant of guideline recommended doses of heart failure medication, documented evidence must be available.\n\n   Guideline directed medical therapy includes for:\n\n   • Patients with HFrEF:\n\n   \\- Angiotensin-converting enzyme inhibitor (ACE-I) or\n\n   \\- Angiotensin receptor-neprilysin inhibitor (ARNI)\n\n   \\- Beta-blocker\n\n   \\- Mineralocorticoid receptor antagonist (MRA)\n\n   \\- Dapagliflozin\u002FEmpagliflozin inhibitor (SGLT2i)\n   * Patients with HFmrEF - Diuretics (if symptomatic)\n\n     * Dapagliflozin\u002FEmpagliflozin inhibitor (SGLT2i)\n7. Patients who can perform a non-assisted 6-minute walk test.\n8. Patients must have a body mass index within the range of 20 - 36 kg\u002Fm².\n9. Informed consent in writing obtained from patient.\n\nExclusion Criteria:\n\nPatients who are not likely to experience improvement of their chronic heart failure by the microcurrent therapy, because the causes of the disease cannot be influenced even if the patients fulfill the indication for use of the device or if the therapy with the C-MIC System is not possible or might be associated with unknown risks:\n\n1. Patients who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.\n2. Patients with an indication for a CRT system according to current guidelines.\n3. Patients who have been hospitalized for heart failure which required the use of inotropic support within 30 days before screening.\n4. Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.\n5. Patients with hemoglobin blood level \\\u003C 12 g\u002Fdl in male and \\\u003C 10 g\u002Fdl in female patients.\n6. Patients with primary pulmonary hypertension\n7. Patients who have genetic connective tissue disease (for example Marfan syndrome).\n8. Patients with a prosthetic tricuspid valve.\n9. Patients in whom access for implantation of the leads cannot be obtained (i.e. known venous occlusion, post radiation therapy).\n10. Patient with other features (i.e. thorax deformity) that in the eyes of the investigator make the straightforward placement of the device seem unlikely.\n11. Patients with a pacemaker, an ICD system, a CRT system or with a CCM system.\n12. Current pregnancy or\n13. Breastfeeding\u002Flactating women\n14. 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.\n\n    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.\n15. Patients whose exercise tolerance is limited by a condition other than heart failure (e.g. chronic obstructive pulmonary disease, peripheral vascular 16.\n\nPatients on immunosuppressive therapy. 17.Patie nts with present malignancy. 18. Patients with an active infection considered by the investigator to be unsafe for the patient's participation in the study.\n\n19\\. Patients with renal dysfunction (i.e., estimated glomerular filtration rate \\\u003C45 mL\u002Fmin \u002F1,73 m²). Use the \"CKD-EPI Creatinine Equation (2021)\" as found on https:\u002F\u002Fwww.kidney.org\u002Fprofessionals\u002Fgfr\\_calculator.\n\n20\\. 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 meant by this.\n\n21\\. Patients with a history of drug or alcohol abuse within the 12 months prior to screening.\n\n22\\. 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.\n\n23\\. Participation in any study of an investigational device or drug within 90 days prior to planned study.\n\n24\\. 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).\n\n25\\. Patients who are not able to avoid the following areas (i.e. due to work):\n\n* Areas with strong magnetic fields\n* Areas with strong external electrical influences\n* Areas with a warning notice \"Access prohibited for pacemaker patients\" or similar.\n* Areas with high temperatures","ALL","18 Years","75 Years",{"count":20,"type":21},22,"ESTIMATED","INTERVENTIONAL",[24],"NA","Patients with idiopathic dilated cardiomyopathy in heart failure (NYHA class III - IV) with a baseline left ventricular ejection fraction between ≥25% and ≤35%, and patients with non-ischemic cardiomyopathy in heart failure (NYHA class III-IV) with a baseline left ventricular ejection fraction \\>40% and \\\u003C50% despite guideline-directed medical therapy, will receive C-MIC treatment in addition to optimal medical management.\n\nThe device can be implanted without the need for open-heart surgery. Patients are assigned to one of two groups according to the indications under investigation. At the end of the study after 6 months, the C-MIC System will be turned off. The primary endpoint of the study is the absolute change in left ventricular ejection fraction after 6 months of treatment.",[27,28,29],"Idiopathic Cardiomyopathy","Left Ventricular (LV) Systolic Dysfunction","Non-ischemic Cardiomyopathy",[31,32,33],"dilated cardiomyopathy","heart failure","non-ischemic cardiomyopathy","RECRUITING","2026-03-16",{"date":37,"type":38},"2026-03-18","ACTUAL",{"date":40,"type":38},"2025-04-09",{"date":42,"type":21},"2027-04",{"name":44,"class":45},"Berlin Heals GmbH","INDUSTRY",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100618805","precision-diagnosis-and-risk-stratification-of-rare-cardiomyopathies-based-on-novel-cardiac-magnetic-resonance-techniques-100618805","NCT07336394","Precision Diagnosis and Risk Stratification of Rare Cardiomyopathies Based on Novel Cardiac Magnetic Resonance Techniques","Multimodality Imaging (Cardiovascular Magnetic Resonance Imaging, Echocardiography, and Nuclear Medicine Imaging) in the Screening, Diagnosis and Risk Stratification of Rare Cardiomyopathies - a Multicenter Study","Inclusion Criteria:\n\n* Patients who have received a cardiac magnetic resonance examination since 2010 and have a suspicion of rare cardiomyopathy.\n\nExclusion Criteria:\n\n* Severe arrhythmia;\n* Severe primary cardiac valvular disease;\n* Refuse to participate in the study.",true,{"count":56,"type":21},1000,"10 Years","OBSERVATIONAL","What is this study about? This research is focused on improving the care for people with rare heart muscle diseases, known as rare cardiomyopathies. These are uncommon conditions where the heart muscle becomes stiff, thick, or enlarged, making it harder for the heart to pump blood. Because they are rare, they can be difficult to diagnose and manage.\n\nThe investigators are testing new, advanced ways of using a heart scan called a Cardiac Magnetic Resonance (CMR). Participants can think of a CMR as a very powerful camera that takes detailed pictures of their heart without using radiation.\n\nWhat is the study trying to learn? Better Diagnosis: The investigators want to see if these new scanning techniques can help us identify these rare heart conditions more clearly and accurately. This means patients could get a correct diagnosis sooner.\n\nPersonalized Risk Assessment: The investigators want to see if the scan can help us understand the future risk for each patient better. For example, can it help predict which patients are more likely to have a heart rhythm problem or need specific treatments? This helps doctors create a care plan that is tailored just for participants.\n\nWhat does this mean for participants? If participants choose to take part, they will undergo a CMR scan that uses these new techniques. By participating, they will be helping us find better ways to diagnose and care for people with their condition in the future. The goal is to turn uncertainty into clearer, more personalized information for patients and families.",[61,62,63,64,65,66,27],"Danon Disease","Fabry Disease","Cardiac Amyloidosis","Noonan Syndrome","Cardiac Sarcoidosis","Glycogen Storage Disease",[68,69,70,71,72,73],"cardiovascular magnetic resonance imaging","early diagnosis","prognosis","rare cardiomyopathies","nuclear medicine imaging","echocardiography","2026-01-19",{"date":76,"type":38},"2026-01-21",{"date":78,"type":38},"2010-01-01",{"date":80,"type":21},"2030-12-30",{"name":82,"class":83},"Chinese Academy of Medical Sciences, Fuwai Hospital","OTHER",1]