Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-01 @ 8:37 PM
Study NCT ID:
NCT01000532
Status:
COMPLETED
Last Update Posted:
2011-11-16
First Post:
2009-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-15', 'studyFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2009-10-22', 'lastUpdatePostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['steroid, leads, threshold, pacemaker'], 'conditions': ['Arrhythmias, Cardiac']}, 'referencesModule': {'references': [{'pmid': '23913463', 'type': 'DERIVED', 'citation': 'Kutyifa V, Zima E, Molnar L, Kuehne C, Theiss S, Herrmann G, Geller L, Merkely B. Direct comparison of steroid and non-steroid eluting small surface pacing leads: randomized, multicenter clinical trial. Cardiol J. 2013;20(4):431-8. doi: 10.5603/CJ.2013.0103.'}]}, 'descriptionModule': {'briefSummary': 'This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with standard pacemaker indication who are refered to the hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the indications for pacemaker therapy\n* Understand the nature of the procedure\n* Give informed consent\n* Able to complete all testing required by the clinical protocol\n* Available for follow-up visits on a regular basis at the investigational site\n\nExclusion Criteria:\n\n* Meet none of the pacemaker indications\n* Meet one or more of the contraindications\n* Have a life expectancy of less than six months\n* Cardiac surgery in the next six months\n* Enrolled in another cardiac clinical investigation\n* Have other medical devices that may interact with the implanted pacemaker'}, 'identificationModule': {'nctId': 'NCT01000532', 'briefTitle': 'SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)', 'orgStudyIdInfo': {'id': '47-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pacemaker therapy', 'interventionNames': ['Device: SIELLO JT/T', 'Device: Pacemaker therapy', 'Device: BPPU JT/T']}], 'interventions': [{'name': 'SIELLO JT/T', 'type': 'DEVICE', 'otherNames': ['BPPU JT/T'], 'description': 'Implantation of SIELLO and BPPU pacemaker leads', 'armGroupLabels': ['Pacemaker therapy']}, {'name': 'Pacemaker therapy', 'type': 'DEVICE', 'description': 'Pacemaker therapy', 'armGroupLabels': ['Pacemaker therapy']}, {'name': 'BPPU JT/T', 'type': 'DEVICE', 'description': 'Implantation of SIELLO and BPPU pacemaker leads', 'armGroupLabels': ['Pacemaker therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Béla Merkely, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University Heart Center, Budapest, Hungary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}