Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 6:49 PM
Study NCT ID:
NCT00757666
Status:
TERMINATED
Last Update Posted:
2017-06-14
First Post:
2008-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
APPROPRIATE - Rate Adaptive Pacing Sensor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cshd@bsci.com', 'phone': '651-582-2277', 'title': 'Director of Clinical Affairs', 'organization': 'Boston Scientific'}, 'certainAgreement': {'otherDetails': 'The first publication of the results shall be made a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed. As the study was stopped early, the primary objective is underpowered.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Accelerometer', 'description': 'Accelerometer', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 6, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Minute Ventilation', 'description': 'Minute ventilation', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 8, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cardiovascular Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Functional Capacity (Peak VO2).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minute Ventilation'}, {'id': 'OG001', 'title': 'Accelerometer'}], 'timeFrame': '1 month and 2 months post-implant', 'description': 'The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor.\n\nThe mean change in functional capactity will be compared against baseline; changes from baseline will be measured.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.'}, {'type': 'SECONDARY', 'title': 'Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Accelerometer', 'description': 'Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.\n\nRate adaptive pacemaker: Accelerometer sensor'}, {'id': 'OG001', 'title': 'Minute Ventilation', 'description': 'Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.\n\nRate adaptive pacemaker: Minute ventilation sensor'}], 'timeFrame': '2 months post-implant', 'description': 'This outcome measure will be compared against baseline.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.'}, {'type': 'SECONDARY', 'title': 'Metabolic Chronotropic Relationship (MCR) Slope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Accelerometer', 'description': 'Accelerometer'}, {'id': 'OG001', 'title': 'Minute Ventilation', 'description': 'Minute ventilation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '1 month and 2 months post-implant', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.'}, {'type': 'SECONDARY', 'title': 'Exercise Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Accelerometer', 'description': 'Accelerometer'}, {'id': 'OG001', 'title': 'Minute Ventilation', 'description': 'Minute ventilation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '1 month and 2 months post-implant', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.'}, {'type': 'SECONDARY', 'title': 'VO2 at Ventilatory Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Accelerometer', 'description': 'Accelerometer'}, {'id': 'OG001', 'title': 'Minute Ventilation', 'description': 'Minute ventilation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '1 month and 2 months post-implant', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Accelerometer', 'description': 'Accelerometer'}, {'id': 'FG001', 'title': 'Minute Ventilation', 'description': 'Minute ventilation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '566 subjects enrolled, of which 68 had all visits completed at the time of study termination.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of patients with complete CPX test results from 1 month and 2 month visits', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'Number of patients with complete CPX test results from 1 month and 2 month visits', 'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Accelerometer', 'description': 'Accelerometer'}, {'id': 'BG001', 'title': 'Minute Ventilation', 'description': 'Minute ventilation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '70.4', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 566}}, 'statusModule': {'whyStopped': 'Difficulty enrollment; higher than planned patient attrition and data attrition', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2008-09-19', 'resultsFirstSubmitDate': '2012-01-24', 'studyFirstSubmitQcDate': '2008-09-22', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-17', 'studyFirstPostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Functional Capacity (Peak VO2).', 'timeFrame': '1 month and 2 months post-implant', 'description': 'The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor.\n\nThe mean change in functional capactity will be compared against baseline; changes from baseline will be measured.'}], 'secondaryOutcomes': [{'measure': 'Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test', 'timeFrame': '2 months post-implant', 'description': 'This outcome measure will be compared against baseline.'}, {'measure': 'Metabolic Chronotropic Relationship (MCR) Slope', 'timeFrame': '1 month and 2 months post-implant'}, {'measure': 'Exercise Time', 'timeFrame': '1 month and 2 months post-implant'}, {'measure': 'VO2 at Ventilatory Threshold', 'timeFrame': '1 month and 2 months post-implant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pacemaker'], 'conditions': ['Heart Diseases']}, 'descriptionModule': {'briefSummary': 'The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets or met current pacemaker implantation indications\n* Willing and capable of providing informed consent for participation\n* Receiving a dual-chamber pacemaker or previously received a dual-chamber pacemaker with active atrial and ventricular leads\n* Plans to remain in the long-term care of his/her enrolling physician and is available for study follow-up for three months post-enrollment\n\nExclusion Criteria:\n\n* Mobitz II second degree heart block\n* Third degree heart block\n* Chronic atrial fibrillation or uncontrolled atrial arrhythmias within the past 90 days prior to consent\n* Neuromuscular, orthopedic, or vascular disability that prevents normal walking or weight carrying (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)\n* A symptom-limited exercise protocol is thought to be dangerous or contra-indicated, including but not limited to changing pattern of chest discomfort or uncontrolled arrhythmias\n* Pulmonary disease as defined by any one of the following:\n\n * Forced Vital Capacity (FVC) or Forced Expiratory Volume in one second (FEV1) \\< 60% of predicted values\n * Use of two or more pulmonary inhalers\n * Use of supplemental oxygen\n * Chronic use of oral steroids for pulmonary disease treatment\n* Life expectancy is less than 12 months due to other medical conditions, per physician discretion\n* Has or indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)\n* Currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study.\n* Younger than 18 years of age\n* Pregnant or planning to become pregnant during the study (method of assessment upon physician's discretion)\n* Unable or unwilling to comply with the protocol requirements"}, 'identificationModule': {'nctId': 'NCT00757666', 'acronym': 'APPROPRIATE', 'briefTitle': 'APPROPRIATE - Rate Adaptive Pacing Sensor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer', 'orgStudyIdInfo': {'id': 'CR-CA-082808-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Accelerometer', 'description': 'Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.', 'interventionNames': ['Device: Rate adaptive pacemaker']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Minute Ventilation', 'description': 'Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.', 'interventionNames': ['Device: Rate adaptive pacemaker']}], 'interventions': [{'name': 'Rate adaptive pacemaker', 'type': 'DEVICE', 'description': 'Accelerometer sensor', 'armGroupLabels': ['Accelerometer']}, {'name': 'Rate adaptive pacemaker', 'type': 'DEVICE', 'description': 'Minute ventilation sensor', 'armGroupLabels': ['Minute Ventilation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Cardiology Association of NE Arkansas', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Genesis Heart Institute', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}], 'overallOfficials': [{'name': 'Michael Giudici, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Genesis Heart Institute'}, {'name': 'F. Roosevelt Gilliam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Associates of NE Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}