Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-05 @ 6:28 PM
Study NCT ID:
NCT00311168
Status:
COMPLETED
Last Update Posted:
2021-08-12
First Post:
2006-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clay.cohorn@abbott.com', 'phone': '469-929-7116', 'title': 'Clay Cohorn - Director, Clinical Research', 'organization': 'Abbott'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months for each intervention', 'description': 'Safety Population included all subjects who were randomized and received at least one of the interventions (VIP On or VIP Off).', 'eventGroups': [{'id': 'EG000', 'title': 'VIP On', 'description': 'VIP On Period', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 0, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VIP Off', 'description': 'VIP Off Period', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 1, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'DIMINISHING R-WAVE AMPLITUDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'LEAD DISLODGEMENT OR MIGRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Intrinsic Ventricular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIP On', 'description': 'VIP On Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}, {'id': 'OG001', 'title': 'VIP Off', 'description': 'VIP Off Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}], 'classes': [{'categories': [{'measurements': [{'value': '82.7', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '31.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-60.2', 'ciLowerLimit': '-67.5', 'ciUpperLimit': '-52.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19', 'estimateComment': 'Mean difference in the percentage of intrinsic ventricular events is presented as, VIP Off - VIP On.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A target of an 80% reduction in percentage of ventricular pacing with VIP™ is proposed in this study. In order to achieve an 80% power of detecting an 80% reduction in the percentage of ventricular paced events and using a two group two-sided t-test of equal means, a minimum sample size of 39 patients per group was required. To account for possible withdrawal or loss to follow-up, this study targeted to enroll 100 patients (50 per group).'}], 'paramType': 'MEAN', 'timeFrame': '6 months after randomization', 'description': 'This outcome measured evaluated the difference in the percentage of intrinsic ventricular events between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.', 'unitOfMeasure': '% of intrinsic ventricular events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.'}, {'type': 'SECONDARY', 'title': 'Incidence of Arrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIP On', 'description': 'VIP On Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}, {'id': 'OG001', 'title': 'VIP Off', 'description': 'VIP Off Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '13', 'groupId': 'OG000'}, {'value': '2', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of time a patient spent in atrial tachycardia/atrial fibrillation (arrhythmia burden) calculated by the device between VIP On and VIP Off.', 'unitOfMeasure': 'percentage of burden', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Atrial Sensing to Ventricular Sensing (%PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIP On', 'description': 'VIP On Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}, {'id': 'OG001', 'title': 'VIP Off', 'description': 'VIP Off Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}], 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of atrial sensing to ventricular sensing (%PR) detected by the device between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.', 'unitOfMeasure': 'percentage of PR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Atrial Sensing to Ventricular Pacing (%PV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIP On', 'description': 'VIP On Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}, {'id': 'OG001', 'title': 'VIP Off', 'description': 'VIP Off Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of Atrial Sensing to Ventricular Pacing (%PV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.', 'unitOfMeasure': 'percentage of PV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Atrial Pacing to Ventricular Sensing (%AR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIP On', 'description': 'VIP On Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}, {'id': 'OG001', 'title': 'VIP Off', 'description': 'VIP Off Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}], 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'spread': '35', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '20.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Sensing (%AR) between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.', 'unitOfMeasure': 'percentage of AR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Atrial Pacing to Ventricular Pacing (%AV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIP On', 'description': 'VIP On Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}, {'id': 'OG001', 'title': 'VIP Off', 'description': 'VIP Off Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '38.1', 'spread': '35.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Pacing (%AV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.', 'unitOfMeasure': 'percentage of AV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Experiencing a Study-Related Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIP On', 'description': 'VIP On Period'}, {'id': 'OG001', 'title': 'VIP Off', 'description': 'VIP Off Period'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the incidence of study-related adverse events between VIP On and VIP Off.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Auto Mode Switch Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIP On', 'description': 'VIP On Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}, {'id': 'OG001', 'title': 'VIP Off', 'description': 'VIP Off Group\n\n* VIP On, then VIP Off\n* VIP Off, then VIP On'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off.', 'unitOfMeasure': 'Counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VIP On, Then VIP Off', 'description': 'Participants first have the VIP algorithm programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.\n\nIntervention/treatment:\n\nDevice: VIP On Device: VIP Off'}, {'id': 'FG001', 'title': 'VIP Off, Then VIP On', 'description': 'Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.\n\nIntervention/treatment:\n\nDevice: VIP Off Device: VIP On'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '134 of 135 subjects were randomized. One subject was not randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VIP On, Then VIP Off', 'description': 'Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.\n\nIntervention/treatment:\n\nDevice: VIP On Device: VIP Off'}, {'id': 'BG001', 'title': 'VIP Off, Then VIP On', 'description': 'Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.\n\nIntervention/treatment:\n\nDevice: VIP On Device: VIP Off'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.3', 'spread': '16.1', 'groupId': 'BG000'}, {'value': '75.6', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '74.0', 'spread': '13.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '67/68 subjects (VIP On, then VIP Off) and 64/66 subjects (VIP Off, then VIP On) have gender information collected on the CRF'}], 'populationDescription': 'A total of 135 subjects were enrolled in the study and 134 of these 135 subjects were randomized. The 134 randomized subjects are included in the baseline analysis population.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2006-04-03', 'resultsFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2006-04-04', 'lastUpdatePostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-29', 'studyFirstPostDateStruct': {'date': '2006-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Intrinsic Ventricular Events', 'timeFrame': '6 months after randomization', 'description': 'This outcome measured evaluated the difference in the percentage of intrinsic ventricular events between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Arrhythmias', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of time a patient spent in atrial tachycardia/atrial fibrillation (arrhythmia burden) calculated by the device between VIP On and VIP Off.'}, {'measure': 'Percentage of Atrial Sensing to Ventricular Sensing (%PR)', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of atrial sensing to ventricular sensing (%PR) detected by the device between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.'}, {'measure': 'Percentage of Atrial Sensing to Ventricular Pacing (%PV)', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of Atrial Sensing to Ventricular Pacing (%PV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.'}, {'measure': 'Percentage of Atrial Pacing to Ventricular Sensing (%AR)', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Sensing (%AR) between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.'}, {'measure': 'Percentage of Atrial Pacing to Ventricular Pacing (%AV)', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Pacing (%AV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.'}, {'measure': 'Percentage of Patients Experiencing a Study-Related Adverse Event', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the incidence of study-related adverse events between VIP On and VIP Off.'}, {'measure': 'Number of Auto Mode Switch Events', 'timeFrame': '6 months after randomization', 'description': 'This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bradycardia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV delay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks).\n* At the time of pacemaker implant, VIP™ is programmed "OFF".\n* At the time of enrollment, patient is paced in the RV ≤ 60% of the time.\n* Patient is medically stable.\n\nExclusion Criteria:\n\n* Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient\'s routine management.\n* Patient is indicated for AF Suppression.\n* Patient has persistent or chronic atrial fibrillation.\n* Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.\n* Patient is currently participating in another device research study.\n* Patient is younger than 18 years of age.\n* Patient is pregnant.\n* Patients life expectancy is less than 12 months.'}, 'identificationModule': {'nctId': 'NCT00311168', 'briefTitle': 'Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study', 'orgStudyIdInfo': {'id': 'CRD343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIP On, Then VIP Off', 'description': 'Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.', 'interventionNames': ['Device: Intervention/treatment']}, {'type': 'EXPERIMENTAL', 'label': 'VIP Off, Then VIP On', 'description': 'Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.', 'interventionNames': ['Device: Intervention/treatment']}], 'interventions': [{'name': 'Intervention/treatment', 'type': 'DEVICE', 'description': 'Device: VIP On\n\nDevice: VIP Off', 'armGroupLabels': ['VIP Off, Then VIP On', 'VIP On, Then VIP Off']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Abbott', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}], 'overallOfficials': [{'name': 'Clay Cohorn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}