Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-30 @ 12:00 PM
Study NCT ID:
NCT01832493
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2013-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sensor Optimization of Cardiac Resynchronization Therapy Response
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058406', 'term': 'Cardiac Resynchronization Therapy'}], 'ancestors': [{'id': 'D002304', 'term': 'Cardiac Pacing, Artificial'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medtronicCRMtrials@medtronic.com', 'phone': '1-800-328-2518', 'title': 'Medtronic SOCR Clinical Trial Leader', 'organization': 'Medtronic CRHF'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During implant to 26 days post-implant', 'eventGroups': [{'id': 'EG000', 'title': 'All Enrolled Patients', 'description': 'Adverse events were collected and are reported for all 50 enrolled patients', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Device Stimulation Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anaphylactic Shock', 'notes': 'Allergic reaction to antibiotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AV Interval Determination Using Impedance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Resynchronization Therapy', 'description': 'Patients implanted with a cardiac resynchronization therapy device\n\nCardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During implant', 'description': 'Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all AV intervals of interest.'}, {'type': 'PRIMARY', 'title': 'AV Interval Determination Using Heart Sounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Resynchronization Therapy', 'description': 'Patients implanted with a cardiac resynchronization therapy device\n\nCardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During implant', 'description': 'Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. A heart sounds measure, called S1 Amplitude Transition, is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by heart sounds agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a RV tripolar S1 Amplitude Transition measurement and a LV dP/dT max measurement for all AV intervals of interest.'}, {'type': 'PRIMARY', 'title': 'Optimal Electrode Configuration Determination Using Impedance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Resynchronization Therapy', 'description': 'Patients implanted with a cardiac resynchronization therapy device\n\nCardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During implant', 'description': 'Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Intracardiac impedance is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by intracardiac impedance agrees with the optimal setting determined by LV dP/dt max', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all electrode configurations of interest.'}, {'type': 'PRIMARY', 'title': 'Optimal Electrode Configuration Determination Using Heart Sounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Resynchronization Therapy', 'description': 'Patients implanted with a cardiac resynchronization therapy device\n\nCardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During implant', 'description': 'Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Heart sounds, as measured by S1 Amplitude, is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by heart sounds agrees with the optimal setting determined by LV dP/dt max', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a RV tripolar S1 amplitude measurement and a LV dP/dT max measurement for all electrode configurations of interest.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardiac Resynchronization Therapy Patients', 'description': 'All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Unable to place LV lead', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patient recruitment occurred from September 27, 2013 to January 28, 2016.', 'preAssignmentDetails': 'Eight patients exited the study prior to undergoing the research procedure: Four did not meet inclusion/exclusion criteria; In 2 cases, the physician deemed withdrawal medically necessary; and in 2 cases, the surgeon was unable to place the left ventricular (LV) lead.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cardiac Resynchronization Therapy Patients', 'description': 'All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.1', 'spread': '12.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients undergoing the research procedure'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2013-03-20', 'resultsFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2013-04-15', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-18', 'studyFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AV Interval Determination Using Impedance', 'timeFrame': 'During implant', 'description': 'Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.'}, {'measure': 'AV Interval Determination Using Heart Sounds', 'timeFrame': 'During implant', 'description': 'Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. A heart sounds measure, called S1 Amplitude Transition, is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by heart sounds agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max'}, {'measure': 'Optimal Electrode Configuration Determination Using Impedance', 'timeFrame': 'During implant', 'description': 'Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Intracardiac impedance is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by intracardiac impedance agrees with the optimal setting determined by LV dP/dt max'}, {'measure': 'Optimal Electrode Configuration Determination Using Heart Sounds', 'timeFrame': 'During implant', 'description': 'Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Heart sounds, as measured by S1 Amplitude, is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by heart sounds agrees with the optimal setting determined by LV dP/dt max'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '36574867', 'type': 'DERIVED', 'citation': 'Luo H, Westphal P, Shahmohammadi M, Heckman LIB, Kuiper M, Cornelussen RN, Delhaas T, Prinzen FW. Heart sound-derived systolic time intervals for atrioventricular delay optimization in cardiac resynchronization therapy. Heart Rhythm. 2023 Apr;20(4):572-579. doi: 10.1016/j.hrthm.2022.12.031. Epub 2022 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV) electrodes in patients indicated for cardiac resynchronization therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be undergoing implant of a new or replacement/upgrade Medtronic CRT-P or CRT-D device for approved indications.\n* Subject is implanted or will be implanted with an right ventricular (RV) lead that supports bipolar pacing and sensing (e.g. a bipolar pace/sense lead or a true bipolar defibrillation leads)\n* Subject (or subject's legally authorized representative) must be willing to give informed consent\n* Subjects must be at least 18 years of age\n\nExclusion Criteria:\n\n* Subject has congenital heart disease\n* Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure\n* Subject has unstable coronary artery disease\n* Subject cannot undergo transvenous catheterization\n* Subject has a mechanical tricuspid or aortic valve prosthesis or history of significant structural tricuspid or aortic valvular disease\n* Subject requires dual chamber cardiac pacing or single chamber (ventricular) pacing at rest for rate control\n* Subject has a recent echocardiogram (within prior 6 months) which revealed the presence of an LV thrombus\n* Subject is pregnant\n* Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager"}, 'identificationModule': {'nctId': 'NCT01832493', 'acronym': 'SOCR', 'briefTitle': 'Sensor Optimization of Cardiac Resynchronization Therapy Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Sensor Optimization of CRT Response', 'orgStudyIdInfo': {'id': 'SOCR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiac Resynchronization Therapy', 'description': 'Patients implanted with a cardiac resynchronization therapy device', 'interventionNames': ['Device: Cardiac Resynchronization Therapy']}], 'interventions': [{'name': 'Cardiac Resynchronization Therapy', 'type': 'DEVICE', 'description': 'All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.', 'armGroupLabels': ['Cardiac Resynchronization Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50314-3017', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45014', 'city': 'Fairfield', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Hospital Fairfield', 'geoPoint': {'lat': 39.34589, 'lon': -84.5605}}, {'zip': 'V8R 4R2', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Victoria Cardiac Arrhythmia Trials', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'GIV 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Grantham Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'SOCR Clinical Trial Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medtronic CRHF'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}