Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-31 @ 7:20 PM
Study NCT ID:
NCT00918294
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2009-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2009-02-04', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the aortic velocity time integral value derived by the QuickOptTM optimization method with that derived by the standard echocardiography optimization methods', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Time required for each optimization method considered in this study', 'timeFrame': '1 day'}, {'measure': 'Effects of any spontaneous cardiac events during the QuickOpt optimization process and these events are not limited to premature ventricular complex (PVC), pacemaker-mediated tachycardia (PMT), atrial fibrillation (AF) and far-field R-wave oversensing', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CRT', 'heart failure', 'optimization', 'Timing cycle optimization methods'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '22490397', 'type': 'DERIVED', 'citation': 'Hua W, Wang DM, Cai L, Sun CF, Fu GS, Wang YT, Yan J, Luo ZL, Xu J, Wang ZY, Xu G, Shen FR, Xu W, Wang JF, Ren XJ, Jin W, Zhang N, Lau EO, Zhang S. A prospective study to evaluate the efficacy of an intracardiac electrogram-based atrioventricular and interventricular intervals optimization method in cardiac resynchronization therapy. Chin Med J (Engl). 2012 Feb;125(3):428-33.'}]}, 'descriptionModule': {'briefSummary': 'QuickOptTM optimization method provides a quicker, simpler and reliable alternative to standard echocardiography methods for optimization of sensed AV, paced AV and V-V delays in patients with CRT-P devices'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system\n* Patient is able to provide written informed consent for study participation\n\nExclusion Criteria:\n\n* Patient has limited intrinsic atrial activity (≤ 40 bpm)\n* Patient has persistent or permanent AF\n* Patient has a 2o or 3o heart block\n* Patient is unable to provide analyzable echocardiogram images\n* Patient's life expectancy is \\<12 months\n* Patient is \\<18 years old\n* Patient is pregnant\n* Patient is on IV inotropic agents"}, 'identificationModule': {'nctId': 'NCT00918294', 'acronym': 'QuickOpt', 'briefTitle': 'QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization', 'orgStudyIdInfo': {'id': 'QuickOpt Study Asia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QuickOpt', 'description': 'QuickOpt is an optimization algorithm to program the AV, PV and VV delays', 'interventionNames': ['Device: QuickOpt']}], 'interventions': [{'name': 'QuickOpt', 'type': 'DEVICE', 'description': 'The QuickOpt algorithm will suggest values for programming AV, PV and VV delay.', 'armGroupLabels': ['QuickOpt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'country': 'China', 'facility': 'Fu Wai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}