Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT01039467
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2009-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zsfuwai@vip.163.com', 'phone': '861088398833', 'title': 'Dr. Shu Zhang', 'organization': 'Fuwai Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing (MVP)', 'otherNumAtRisk': 196, 'otherNumAffected': 2, 'seriousNumAtRisk': 196, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Search AV+', 'description': 'Search AV+ (SAV+)', 'otherNumAtRisk': 189, 'otherNumAffected': 3, 'seriousNumAtRisk': 189, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death (unknown reason)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden cardiac death (CHD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac death (cancer)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac death (cerebrovascular accident）', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pocket infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgement of RV lead and reposition of the lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing (MVP)'}, {'id': 'OG001', 'title': 'Search AV+', 'description': 'Search AV+ (SAV+)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month post-implantation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the 1 month visit with %VP data available.'}, {'type': 'SECONDARY', 'title': 'Percent of Ventricular Pacing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing (MVP)'}, {'id': 'OG001', 'title': 'Search AV+', 'description': 'Search AV+ (SAV+)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'spread': '31.46', 'groupId': 'OG000'}, {'value': '2.95', 'spread': '40.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 months post-implantation', 'unitOfMeasure': 'percent of ventricular pacing (%VP)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the 12 months visit with %VP data available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing (MVP)'}, {'id': 'OG001', 'title': 'Search AV+', 'description': 'Search AV+ (SAV+)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.40', 'spread': '20.27', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '25.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.833', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '1 month post-implantation', 'description': 'To compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients by measuring the percent burden of atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.', 'unitOfMeasure': 'Percentage of decreasedAT/AF burden', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the 1 month visit with\n\n%AT/AF burden data available.'}, {'type': 'SECONDARY', 'title': 'Change in Percent of Ventricular Pacing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing (MVP)'}, {'id': 'OG001', 'title': 'Search AV+', 'description': 'Search AV+ (SAV+)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '20.20', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '20.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.265', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'from 1 month to 12 months post-implantation', 'unitOfMeasure': 'percent of ventricular pacing (%VP)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the 12 months visit with %VP data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing (MVP)'}, {'id': 'OG001', 'title': 'Search AV+', 'description': 'Search AV+ (SAV+)'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month post-implantation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the 12 months visit with %VP data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No AV Block', 'description': 'Patients with no atrioventricular block'}, {'id': 'OG001', 'title': 'nAVB', 'description': 'Patients with atrioventricular block'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month post-implantation', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the 1 month visit with %VP data available.'}, {'type': 'SECONDARY', 'title': 'Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing (MVP)'}, {'id': 'OG001', 'title': 'Search AV+', 'description': 'Search AV+ (SAV+)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '23.65', 'groupId': 'OG000'}, {'value': '21.80', 'spread': '41.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '1 month post-implantation', 'unitOfMeasure': 'percent of ventricular pacing (%VP)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the 1 month visit with %VP data available.'}, {'type': 'SECONDARY', 'title': 'Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing (MVP)'}, {'id': 'OG001', 'title': 'Search AV+', 'description': 'Search AV+ (SAV+)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.40', 'spread': '39.16', 'groupId': 'OG000'}, {'value': '80.60', 'spread': '44.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '1 month post-implantation', 'unitOfMeasure': 'percent of ventricular pacing (%VP)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the 1 month visit with %VP data available.'}, {'type': 'SECONDARY', 'title': 'Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing (MVP)'}, {'id': 'OG001', 'title': 'Search AV+', 'description': 'Search AV+ (SAV+)'}], 'classes': [{'categories': [{'measurements': [{'value': '79.20', 'spread': '44.68', 'groupId': 'OG000'}, {'value': '22.45', 'spread': '47.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.493', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '1 month post-implantation', 'unitOfMeasure': 'percent of ventricular pacing (%VP)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the 1 month visit with %VP data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Managed Ventricular Pacing (MVP)', 'description': 'Managed Ventricular Pacing (MVP) used in dual chamber pacemaker'}, {'id': 'FG001', 'title': 'Search AV+', 'description': 'Search AV+ used in dual chamber pacemaker'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '189'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '49'}]}]}], 'recruitmentDetails': 'Enrollment period: 18 JUN 2009 to 15 MAR 2010.', 'preAssignmentDetails': '6 patients withdrawn from study pre-randomization for not meeting inclusion/exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Managed Ventricular Pacing (MVP)', 'description': 'Managed Ventricular Pacing (MVP) used in dual chamber pacemaker'}, {'id': 'BG001', 'title': 'Search AV+', 'description': 'Search AV+ used in dual chamber pacemaker'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.87', 'spread': '10.35', 'groupId': 'BG000'}, {'value': '70.71', 'spread': '9.89', 'groupId': 'BG001'}, {'value': '70.28', 'spread': '10.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2009-12-23', 'resultsFirstSubmitDate': '2016-10-10', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-23', 'studyFirstPostDateStruct': {'date': '2009-12-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+', 'timeFrame': '1 month post-implantation'}], 'secondaryOutcomes': [{'measure': 'Percent of Ventricular Pacing', 'timeFrame': '12 months post-implantation'}, {'measure': 'Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant', 'timeFrame': '1 month post-implantation', 'description': 'To compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients by measuring the percent burden of atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.'}, {'measure': 'Change in Percent of Ventricular Pacing', 'timeFrame': 'from 1 month to 12 months post-implantation'}, {'measure': 'Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)', 'timeFrame': '1 month post-implantation'}, {'measure': 'Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)', 'timeFrame': '1 month post-implantation'}, {'measure': 'Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)', 'timeFrame': '1 month post-implantation'}, {'measure': 'Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)', 'timeFrame': '1 month post-implantation'}, {'measure': 'Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)', 'timeFrame': '1 month post-implantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Managed Ventricular Pacing'], 'conditions': ['Bradycardia']}, 'descriptionModule': {'briefSummary': 'The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China. The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients. The COMPARE-Adapta study will also observe atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.', 'detailedDescription': 'Recent studies suggest that chronic right ventricular pacing is associated with a variety of adverse effects in patients, particularly those with intact or intermittent atrioventricular (AV) conduction.\n\nMedtronic Adapta® pacemakers include Managed Ventricular Pacing®, a pacing mode designed to promote intrinsic conduction, and also Search AV™+, a feature designed to reduce unnecessary ventricular pacing in patients with intact or intermittent AV conduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated study informed consent\n* Class I or Class IIa pacemaker indication\n* Geographically stable and available for follow-up at the center for the length of the study\n* Age greater than 18\n* To be implanted with Adapta dual chamber pacemaker\n\nExclusion Criteria:\n\n* Unwillingness or inability to give written informed consent to participate in the Study\n* Patient with a previously implanted pacemaker/Implantable Cardioverter-Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT) device\n* Life expectancy of less than one year\n* Patient has a mechanical tricuspid heart valve\n* Medical conditions that preclude the testing requirement by the protocol or limit study participation\n* Patient has persistent 3rd degree atrioventricular (AV) block\n* Patient has persistent atrial fibrillation (AF)\n* Patient has neurogenic syncope\n* Patient has carotid sinus syndrome\n* Patient has hypertrophic obstructive cardiomyopathy\n* Inclusion in another clinical trial or study'}, 'identificationModule': {'nctId': 'NCT01039467', 'acronym': 'COMPARE', 'briefTitle': 'A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Study of a Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing', 'orgStudyIdInfo': {'id': 'COMPARE Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Managed Ventricular Pacing', 'description': 'Managed Ventricular Pacing group: programmed on', 'interventionNames': ['Device: Medtronic Adapta Dual Chamber Pacemaker']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Search AV+', 'description': 'Search AV+: programmed on', 'interventionNames': ['Device: Medtronic Adapta Dual Chamber Pacemaker']}], 'interventions': [{'name': 'Medtronic Adapta Dual Chamber Pacemaker', 'type': 'DEVICE', 'description': 'Medtronic Adapta Dual Chamber Pacemaker', 'armGroupLabels': ['Managed Ventricular Pacing', 'Search AV+']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': '3rd Hospital of Beijing University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Province Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': '1st Hospital of Zhongshan Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': '2nd Hospital of Zhongshan Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Province People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': '1st Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Asian Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Second Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': '2nd Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': "Liaoning Province People's Hospital", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'Affiliated Hospital of Qingdao Medical College', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Huadong Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Minhang District Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'General Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Xinjiang Automatic District Hospital', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': '1st Hospital of Kunming Medical College', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': "Yunnan Province 1st People's Hospital", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Yuxi', 'state': 'Yunnan', 'country': 'China', 'facility': "Yuxi People's Hospital", 'geoPoint': {'lat': 24.355, 'lon': 102.54222}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': '1st Hospital of Medical College, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': '2nd Hospital of Medical College, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shu Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}