Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-04 @ 6:17 AM
Study NCT ID:
NCT05189860
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The C-MIC-II Follow-Up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2021-12-27', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '2 years', 'description': 'Rate of all cause, cardiac and device related mortality'}, {'measure': 'Hospitalizations', 'timeFrame': '2 years', 'description': 'Rate of all-cause, cardiac and device related hospitalizations'}, {'measure': 'Adverse events', 'timeFrame': '2 years', 'description': 'Overall incidence and severity of adverse events including malfunction'}], 'secondaryOutcomes': [{'measure': 'Change in cardiac performance', 'timeFrame': '2 Years', 'description': 'Left ventricular ejection fraction'}, {'measure': 'Treatment adjustment', 'timeFrame': '2 Years', 'description': 'Need for prolonged therapy with the C-MIC System in responder patients'}, {'measure': 'Patient related outcome', 'timeFrame': '2 years', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status'}, {'measure': 'Change in New York Heart Association (NYHA) classification', 'timeFrame': '2 years', 'description': 'NYHA functional class'}, {'measure': 'Cange in exercise ability', 'timeFrame': '2 years', 'description': 'Cardiopulmonary exercise test'}, {'measure': 'Change in aerobic capacity and endurance', 'timeFrame': '2 years', 'description': '6 Minute walk test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systolic Left Ventricular Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/ct2/show/NCT04662034', 'label': 'Parent trial'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT05189860', 'acronym': 'C-MIC-II-FU', 'briefTitle': 'The C-MIC-II Follow-Up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Berlin Heals GmbH'}, 'officialTitle': 'The C-MIC-II Follow-Up Study', 'orgStudyIdInfo': {'id': 'C-MIC-II-FU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-MIC Device', 'description': 'Device plus Standard of Care', 'interventionNames': ['Device: C-MIC system']}], 'interventions': [{'name': 'C-MIC system', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['C-MIC Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000', 'city': 'Banja Luka', 'state': 'Banja Luka', 'status': 'NOT_YET_RECRUITING', 'country': 'Bosnia and Herzegovina', 'facility': 'University Clinical Centre of Republic of Srpska', 'geoPoint': {'lat': 44.77879, 'lon': 17.20629}}, {'zip': '71000', 'city': 'Sarajevo', 'state': 'Sarajevo', 'status': 'NOT_YET_RECRUITING', 'country': 'Bosnia and Herzegovina', 'facility': 'University Clinical Center of Sarajevo', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'zip': '10000', 'city': 'Zagreb', 'state': 'City of Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Igor Rudez, MD', 'role': 'CONTACT'}], 'facility': 'Clinical Hospital Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '1000', 'city': 'Skopje', 'status': 'RECRUITING', 'country': 'North Macedonia', 'facility': 'University Clinic Cardiac Surgery', 'geoPoint': {'lat': 41.99646, 'lon': 21.43141}}, {'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Clinical Center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Clinical Hospital Center Bezanijska Kosa', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'centralContacts': [{'name': 'Peter Goettel, MD', 'role': 'CONTACT', 'email': 'goettel@berlinheals.de', 'phone': '+49 30 88913640', 'phoneExt': '61'}, {'name': 'Kersten Brandes, MD', 'role': 'CONTACT', 'email': 'brandes@berlinheals.de', 'phone': '+49 30 88913640', 'phoneExt': '66'}], 'overallOfficials': [{'name': 'Peter Goettel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Berlin Heals GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Berlin Heals GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}