Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-31 @ 11:49 AM
Study NCT ID:
NCT01789112
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2013-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of a Non Excitatory Cardial Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2013-02-08', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive inotropic effects by CCM stimulation', 'timeFrame': '15 minutes'}]}, 'conditionsModule': {'conditions': ['CCM Implantation']}, 'descriptionModule': {'briefSummary': 'Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* planned CCM Implantation\n* systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV)\n* implanted pacemaker, defibrillator or pacemaker during CS intubation\n* written informed consent\n* open entryways\n\nExclusion Criteria:\n\n* anemia Hemoglobin (HB)\\<8 mg/dl\n* lying coronary sinus (CS) tube or CS being not able to intubate\n* chronic atrial fibrillation or flutter\n* mechanic tricuspid valve prothesis\n* no access via subclavian vein\n* patients with VVI pacemaker being stimulated 110%\n* idiopathic hypertrophic cardiomyopathy, restrictive constrictive cardiomyopathy or heart failure because of known inflammatory or infiltrative illnesses or constrictive illness\n* acute myocardial ischemia presented by angina pectoris or ECG changes under load\n* patients being hospitalized because of heart failure during the last month and have to be treated with intravenous diuretics or inotropic substances\n* acute coronary syndrome should not be implanted for at least 3 month\n* patients with mechanic aortic or tricuspid valve\n* patients after heart transplantation\n* patients with clinical significant ectopy, defined by \\> 8.900 PVCs during 24 hours at beginning Holter monitoring\n* patients after hypertensive crisis\n* patients with acute renal failure\n* Ejection Fraction (EF) \\> 35\n* patients after left ventricular pacemaker electrode\n* pregnant or breast feeding women\n* patients with heart failure after sepsis'}, 'identificationModule': {'nctId': 'NCT01789112', 'briefTitle': 'Acute Effects of a Non Excitatory Cardial Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure', 'orgStudyIdInfo': {'id': '12-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CCM aggregate', 'description': 'Taking of 10 blood samples', 'interventionNames': ['Other: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': 'Taking of blood sample', 'armGroupLabels': ['CCM aggregate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine Westfalia', 'country': 'Germany', 'facility': 'Univeristy Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Sebastian Reith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RWTH Aachen, Medical Departement I Univerity Hospital Aachen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}