[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453847":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":47,"studyPopulation":39,"armGroups":48,"interventions":55,"overallOfficials":61,"centralContacts":65,"locations":75,"responsibleParty":140,"collaborators":39,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":39,"studyType":155,"phases":156,"briefSummary":157,"conditions":158,"keywords":39,"overallStatus":100,"whyStopped":39,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Berlin Heals GmbH","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":39},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Mortality","Rate of all cause, cardiac and device related mortality","2 years",{"measure":14,"description":15,"timeFrame":12},"Hospitalizations","Rate of all-cause, cardiac and device related hospitalizations",{"measure":17,"description":18,"timeFrame":12},"Adverse events","Overall incidence and severity of adverse events including malfunction",[20,24,27,30,33,36],{"measure":21,"description":22,"timeFrame":23},"Change in cardiac performance","Left ventricular ejection fraction","2 Years",{"measure":25,"description":26,"timeFrame":23},"Treatment adjustment","Need for prolonged therapy with the C-MIC System in responder patients",{"measure":28,"description":29,"timeFrame":12},"Patient related outcome","Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status",{"measure":31,"description":32,"timeFrame":12},"Change in New York Heart Association (NYHA) classification","NYHA functional class",{"measure":34,"description":35,"timeFrame":12},"Cange in exercise ability","Cardiopulmonary exercise test",{"measure":37,"description":38,"timeFrame":12},"Change in aerobic capacity and endurance","6 Minute walk test",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":39,"timePerspective":39,"maskingInfo":45},"NA","SINGLE_GROUP","Study objective is to assess the safety of the C-MIC System in case of system extended use or abandonment or explantation in patients having received a C-MIC System in the context of a prior study.","TREATMENT",{"masking":46,"maskingDescription":39,"whoMasked":39},"NONE","The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart. The therapy with the C-MIC System is intended to take 6 months.\n\nThe C-MIC System consists of four parts, of which three are implanted: a transvenous and an epicardial lead and a power source to which the leads are connected. Both leads have the function to transmit micro-current to the heart. A Portable User Terminal (PUT) is needed for programming and readout of the data recorded by the Implantable Microcurrent Device (IMD).\n\nTarget patients of the C-MIC System at the time of implantation and inclusion in the C-MICII Study were patients with idiopathic dilative cardiomyopathy (NYHA class III - NYHA class who have systolic left ventricular dysfunction despite adequate therapy of heart failure.\n\nTarget patients for this study are patients who have received the device in a prior study.",[49],{"label":50,"type":51,"description":52,"interventionNames":53},"C-MIC Device","EXPERIMENTAL","Device plus Standard of Care",[54],"Device: C-MIC system",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":39},"DEVICE","C-MIC system","This study aims to follow up patients already treated with a C-MIC System over a period of 2 years following the initial treatment with the device, to assess the long term results.",[50],[62],{"name":63,"affiliation":5,"role":64},"Peter Goettel, MD","STUDY_CHAIR",[66,71],{"name":63,"role":67,"phone":68,"phoneExt":69,"email":70},"CONTACT","+49 30 88913640","61","goettel@berlinheals.de",{"name":72,"role":67,"phone":68,"phoneExt":73,"email":74},"Kersten Brandes, MD","66","brandes@berlinheals.de",[76,89,98,114,125,135],{"facility":77,"status":78,"city":79,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":39},"University Clinical Centre of Republic of Srpska","NOT_YET_RECRUITING","Banja Luka","78000","Bosnia and Herzegovina","BA",{"type":84,"coordinates":85},"Point",[86,87],17.20629,44.77879,{"lat":87,"lon":86},{"facility":90,"status":78,"city":91,"state":91,"zip":92,"country":81,"countryCode":82,"cosmosGeoPoint":93,"geoPoint":97,"contacts":39},"University Clinical Center of Sarajevo","Sarajevo","71000",{"type":84,"coordinates":94},[95,96],18.35644,43.84864,{"lat":96,"lon":95},{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Clinical Hospital Dubrava","RECRUITING","Zagreb","City of Zagreb","10000","Croatia","HR",{"type":84,"coordinates":107},[108,109],15.97798,45.81444,{"lat":109,"lon":108},[112],{"name":113,"role":67,"phone":39,"phoneExt":39,"email":39},"Igor Rudez, MD",{"facility":115,"status":100,"city":116,"state":39,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":39},"University Clinic Cardiac Surgery","Skopje","1000","North Macedonia","MK",{"type":84,"coordinates":121},[122,123],21.43141,41.99646,{"lat":123,"lon":122},{"facility":126,"status":100,"city":127,"state":39,"zip":39,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":134,"contacts":39},"Clinical Center of Serbia","Belgrade","Serbia","RS",{"type":84,"coordinates":131},[132,133],20.46513,44.80401,{"lat":133,"lon":132},{"facility":136,"status":100,"city":127,"state":39,"zip":39,"country":128,"countryCode":129,"cosmosGeoPoint":137,"geoPoint":139,"contacts":39},"Clinical Hospital Center Bezanijska Kosa",{"type":84,"coordinates":138},[132,133],{"lat":133,"lon":132},{"type":141,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100453847","the-c-mic-ii-follow-up-study-100453847",false,"NCT05189860","The C-MIC-II Follow-Up Study","C-MIC-II-FU","Inclusion Criteria:\n\n* Patients who have received a C-MIC System during the C-MIC-II Study.\n* Informed consent in writing from the patient.\n\nExclusion Criteria:\n\n* Patients who are unwilling or unable to participate in the study visits.\n* Vulnerable Patients.","ALL","18 Years","75 Years",{"count":153,"type":154},31,"ESTIMATED","INTERVENTIONAL",[41],"The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart.\n\nTarget patients for this study are patients who have received the device in a prior study.",[159],"Systolic Left Ventricular Dysfunction","2025-06-05",{"date":162,"type":163},"2025-06-08","ACTUAL",{"date":165,"type":163},"2022-03-03",{"date":167,"type":154},"2026-11-15",{"name":5,"class":6},6]