Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT03360227
Status:
RECRUITING
Last Update Posted:
2020-02-07
First Post:
2017-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry of Device Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013575', 'term': 'Syncope'}, {'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}], 'ancestors': [{'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-27', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'device related adverse events', 'timeFrame': 'during index hospital admission', 'description': 'Adverse events as occurrence of perioperative and postoperative complication related to the device implantation during the index hospital admission'}, {'measure': 'Adverse Events', 'timeFrame': 'during index hospital admission', 'description': 'Adverse Events as occurrence of atrial fibrillation, occurrence of syncope, occurrence of sustained ventricular tachycardia (VT), ventricular fibrillation (VF) or appropriate ICD therapy including antitachycardia pacing (ATP) and shock, occurrence of inadequate ICD therapy including ATP and shock in ICD/CRT-D patients, hospital admission due to cardiac disease and therapy, cardiac death'}], 'secondaryOutcomes': [{'measure': 'survival', 'timeFrame': '12 months'}, {'measure': 'Clinical Events', 'timeFrame': '12 months', 'description': 'free from clinical events (death, syncope, hospital admission due to cardiac problems, and VT storm \\[defined as more than three VT episodes in 24 hours\\])'}, {'measure': 'hospitalization', 'timeFrame': '12 months', 'description': 'hospitalization due to cardiac disease and therapy'}, {'measure': 'number of appropriate and inappropriate ICD therapies (ATP or shock)', 'timeFrame': '12 months', 'description': 'number of appropriate and inappropriate ICD therapies (ATP or shock)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['syncope', 'bradycardia', 'tachycardia', 'sudden cardiac death', 'implantable cardioverter-defibrillator', 'ventricular tachycardia', 'ventricular fibrillation', 'biomarker', 'thyroid hormone'], 'conditions': ['Syncope', 'Bradycardia', 'Tachycardia', 'Sudden Cardiac Death', 'Ventricular Tachycardia', 'Ventricular Fibrillation']}, 'descriptionModule': {'briefSummary': 'The implantable device therapy for cardiac arrhythmias has been an established therapy, and one of the common standard procedures in cardiac clinical practice.\n\nPacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy have been developed since 1960s, and the technologies in this field are still progressively developing. Not only these "traditional" implantable devices, there are multiple new devices for cardiac diseases, such as implantable loop recorder, vagal nerve stimulator and barostimulator.\n\nThe aim of this registry is to demonstrate the efficacy and the safety of standard device implantation procedures and to evaluate/ identify specific factors, including clinical characteristics, laboratory data and procedural data, which predict the prognosis/complication of the patients. These identification will result in further improvement of patients\' care.', 'detailedDescription': "The implantation of cardiac devices has been one of the common standard procedures in the cardiac clinical practice.\n\nPacemakers are implanted for patients with symptomatic bradyarrhythmias. Implantable cardioverter-defibrillators are implanted in order to avoid sudden cardiac death (SCD) in high risk patients such as after myocardial infarction and reduced ejection fraction.\n\nCardiac resynchronization therapy was introduced to improve the prognosis in patients with reduced EF and left bundle branch block. This therapy demonstrated the efficacy in severe heart failure patients.\n\nRecently a new implantable device has been developed also to improve the prognosis of patients with severe heart failure refractory to the maximal therapies at present. This barostimulator activates the baro-reflex and results in higher parasympathetic activity and better outcome in those patients, in whom the sympathetic function is overactivated.\n\nIn patients with cryptogenic stroke or syncope, the implantable loop recorder enables us to monitor the cardiac rhythm continuously for 3 years. With this device, the occult arrhythmias can be revealed and lead patients to the adequate therapy.\n\nAbove mentioned device therapies have been developed since 1960s, and the technologies in this field are still progressively developing. To catch up these advancements, the quality management including the efficacy, safety aspects and the prognosis of the patients should be carefully monitored.\n\nThe aim of the present study is, therefore, to demonstrate the efficacy and the safety of standard device implantation procedures. The patient specific and procedural factors are evaluated to test if those factors predict the prognosis of the patients. These identifications will eventually result in the improvement of future patients' care.\n\nThe data of patients who underwent device implantation since 2011 and those who undergo device implantation till 2019 will be collected, including the basic demographic data, comorbidities, results of laboratory and functional tests. In the latter patients, the peri-procedural data and post-procedural data are also prospectively collected.\n\nThe present study is essentially an observational study. The inclusion in this study does not affect the decision of device implantation itself. The post-procedural therapies, such as medications and device therapies are not due to this registry affected.\n\nAs a sub-project in this registry, biomarkers and thyroid hormone are evaluated to investigate the predictable value of those indices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo cardiac device implantation in University Hospital Düsseldorf', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pre-operative clinical history taking\n2. pre-operative functional investigations (cardiac echo, electrocardiograms)\n3. pre-operative laboratory data evaluation (kidney function, liver function, biomarkers, thyroid hormone, CBC)\n\nExclusion Criteria:\n\n１. no written informed consent'}, 'identificationModule': {'nctId': 'NCT03360227', 'briefTitle': 'Registry of Device Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Registry of Device Implantation in University Hospital Duesseldorf', 'orgStudyIdInfo': {'id': '15-019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'implantation of cardiac devices', 'type': 'DEVICE', 'description': 'implantation of cardiac devices'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hisaki Makimoto, MD', 'role': 'CONTACT'}, {'name': 'Rabea Wagstaff, M.A.', 'role': 'CONTACT'}, {'name': 'Hisaki Makimoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alexander Fürnkranz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jan Schmidt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Muhammed Kurt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lukas Clasen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christoph Brinkmeyer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patrick Müller, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandru Bejinariu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Hisaki Makimoto, MD', 'role': 'CONTACT', 'phone': '+492118118800'}], 'overallOfficials': [{'name': 'Hisaki Makimoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}