Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-04 @ 5:09 PM
Study NCT ID:
NCT01454050
Status:
COMPLETED
Last Update Posted:
2012-11-28
First Post:
2011-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumax 740 Master Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2011-10-14', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the automatic Capture Control feature', 'timeFrame': 'PHD, 1-, 3- and 6-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICD therapy', 'RV/LV Capture Control', 'Safety and Efficacy'], 'conditions': ['Safety and Efficacy of the Lumax 740 ICD Family']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with standard ICD indication who are referred to the hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD.\n\n * Legal capacity and ability to consent\n * Signed patient informed consent\n\nIn addition for HF-T devices:\n\n* Bipolar LV-lead with a min. distance of 15 mm between tip and ring\n* True bipolar RV lead\n\nExclusion Criteria:\n\n* Standard contraindication for single, dual, or triple chamber ICD.\n\n * Age \\< 18 years\n * Pregnant or breast-feeding woman\n * Cardiac surgery planned within the next 6 months\n * Life expectancy of less than 6 months\n * Participating in any other clinical study of an investigational cardiac drug or device'}, 'identificationModule': {'nctId': 'NCT01454050', 'acronym': 'Lumax 740', 'briefTitle': 'Lumax 740 Master Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'PME/Master Study of the Lumax 740 ICD Family', 'orgStudyIdInfo': {'id': '55'}}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medical School Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Gunnar Klein, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Herz im Zentrum Hannover, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}