Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-21 @ 10:01 AM
Study NCT ID:
NCT01786993
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MultiPoint Pacing IDE Study
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ccohorn@sjm.com', 'phone': '972-309-8000', 'title': 'Director of Clinical Studies', 'phoneExt': '8087', 'organization': 'St. Jude Medical'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3-month randomization to 9 months', 'description': '* Serious Adverse Events: Events that require invasive intervention (e.g. lead dislodgment requiring repositioning).\n* Other Adverse Events: Events that can be managed without invasive intervention (e.g., oversensing or loss of pacing capture, which is remedied by reprogramming of the pulse generator).', 'eventGroups': [{'id': 'EG000', 'title': 'MultiPoint Pacing Arm', 'description': 'Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.', 'otherNumAtRisk': 201, 'otherNumAffected': 40, 'seriousNumAtRisk': 201, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Biventricular Arm', 'description': 'Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.', 'otherNumAtRisk': 180, 'otherNumAffected': 5, 'seriousNumAtRisk': 180, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'LV Lead Elevated Pacing Thresholds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LV Lead Loss of Capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phrenic Nerve/Diaphragmatic Stimulation Related to LV Lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rise in Threshold And Exit Block Related to LV Lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RA/RV Lead Elevated Pacing Thresholds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RA/RV Lead Loss of Capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RA/RV Lead Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Artifact Observed on Atrial Channel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort Around Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intolerance to MPP Pacing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulse Generator Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker Mediated Tachycardia (PMT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intolerance to BiV Pacing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombo-Embolic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema to Lateral Aspect of Incision Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'LV Lead Dislodgement or Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RA/RV Lead Dislodgement or Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulse Generator Erosion/Extrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Generator Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BiV/MPP Patients', 'description': 'Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.932', 'groupId': 'OG000', 'lowerLimit': '0.904', 'upperLimit': '0.951'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Event-Free Probability', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.932', 'ciLowerLimit': '0.904', 'ciUpperLimit': '0.951', 'groupDescription': 'The hypothesis is formally expressed as:\n\nH0: Freedom from system-related complications through 9 months ≤ 75% Ha: Freedom from system-related complications through 9 months \\> 75%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Implant to 9 months', 'description': 'A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.', 'unitOfMeasure': 'Event-Free Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).'}, {'type': 'PRIMARY', 'title': 'Percentage of Non-responders With MPP Compared to Biventricular Pacing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MultiPoint Pacing Arm', 'description': 'MultiPoint Pacing\n\nMultiPoint Pacing: Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.'}, {'id': 'OG001', 'title': 'Biventricular Arm', 'description': 'Traditional Biventricular Pacing\n\nTraditional Biventricular Pacing: Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0131', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportions', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.049', 'ciLowerLimit': '-0.138', 'groupDescription': 'H0: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) ≤ -0.15\n\nHa: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) \\> -0.15\n\nThe null hypothesis will be rejected at the 2.5% significance level if the lower one-sided 97.5% confidence bound for the difference in the proportions is above -0.15.', 'statisticalMethod': 'normal approximation for binomial dist', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Assuming a binomial distribution with a 44% probability for non-responders between 3 months and 9 months in both study arms, the sample size required for 85% power to reject the null hypothesis at the 5% significance level is 394. To adjust for a potential net crossover of 15% and an overall attrition rate of 20%, the total number of patients required to be enrolled in this study is 506.'}], 'paramType': 'NUMBER', 'timeFrame': '3 months to 9 months', 'description': 'The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient\'s CCS was classified as worsened, improved or unchanged based on the definitions below:\n\n* Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation\n* Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation.\n* Unchanged - patient was neither improved nor worsened\n\nFor patients who were responders at the 3-month visit, those who were "Improved" and "Unchanged" between 3 and 9 months were classified as responders, whereas those who were "Worsened" were grouped together as non-responders.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multi-point Pacing Arm', 'description': 'Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.'}, {'id': 'FG001', 'title': 'Biventricular Arm', 'description': 'Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'Per Protocol Population at 9 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '170'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '170'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'System Explant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Hospice Admission', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study enrolled 506 subjects at 49 investigational centers located in the U.S. A patient was considered enrolled upon signing informed consent. The first subject was enrolled on April 25, 2013. The study was double-blinded (the study subjects and the authorized personnel conducting the NYHA Class and Patient Global assessments were blinded).', 'preAssignmentDetails': '455 out of 469 subjects with an attempted implant (97% success rate) received Quadripolar BiV pacing between implant and 3 months. At 3 months, responder status was assessed per Clincial Composite Score and 1:1 randomziation was stratified by responder status. 381 patients were randomized to either BiV (n = 180) or MPP (n = 201) at 3 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MultiPoint Pacing Arm', 'description': 'Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.'}, {'id': 'BG001', 'title': 'Biventricular Arm', 'description': 'Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '10', 'groupId': 'BG000'}, {'value': '68', 'spread': '10', 'groupId': 'BG001'}, {'value': '68', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic or Latino', 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '366', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'RACE', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'QRS Duration', 'classes': [{'categories': [{'measurements': [{'value': '158', 'spread': '24', 'groupId': 'BG000'}, {'value': '154', 'spread': '20', 'groupId': 'BG001'}, {'value': '156', 'spread': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'QRS Morphology', 'classes': [{'title': 'Left Bundle Branch Block (LBBB)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}]}, {'title': 'Right Bundle Branch Block (RBBB)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Interventricular Conduction Delay (IVCD)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cardiomyopathy Etiology', 'classes': [{'title': 'Ischemic', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}]}, {'title': 'Non-ischemic', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'A total of 381 subjects were randomized at 3 months, of whom 180 were in the BiV arm and 201 were in the MPP arm.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 506}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2013-02-06', 'resultsFirstSubmitDate': '2016-04-15', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-08', 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion', 'timeFrame': 'Implant to 9 months', 'description': 'A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.'}, {'measure': 'Percentage of Non-responders With MPP Compared to Biventricular Pacing', 'timeFrame': '3 months to 9 months', 'description': 'The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient\'s CCS was classified as worsened, improved or unchanged based on the definitions below:\n\n* Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation\n* Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation.\n* Unchanged - patient was neither improved nor worsened\n\nFor patients who were responders at the 3-month visit, those who were "Improved" and "Unchanged" between 3 and 9 months were classified as responders, whereas those who were "Worsened" were grouped together as non-responders.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '33028082', 'type': 'DERIVED', 'citation': 'Varma N, Baker J 2nd, Tomassoni G, Love CJ, Martin D, Sheppard R, Niazi I, Cranke G, Lee K, Corbisiero R. Left Ventricular Enlargement, Cardiac Resynchronization Therapy Efficacy, and Impact of MultiPoint Pacing. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008680. doi: 10.1161/CIRCEP.120.008680. Epub 2020 Oct 7.'}, {'pmid': '29759832', 'type': 'DERIVED', 'citation': 'Niazi I, Baker J 2nd, Corbisiero R, Love C, Martin D, Sheppard R, Worley SJ, Varma N, Lee K, Tomassoni G; MPP Investigators. Safety and Efficacy of Multipoint Pacing in Cardiac Resynchronization Therapy: The MultiPoint Pacing Trial. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1510-1518. doi: 10.1016/j.jacep.2017.06.022. Epub 2017 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.\n\nThe study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.', 'detailedDescription': 'All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant, and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is programmed using any one of the 10 available pacing vectors. The paced/sensed atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site\'s standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up visit.\n\nAt the 3-month visit, responder status between Enrollment and 3 months will be assessed using the Clinical Composite Score (CCS). All subjects that are "Improved" using the definition outlined in the CCS will be grouped together as Responders. All subjects that are "Worsened" or "Unchanged" using the definitions outlined in the CCS will be considered as Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g., Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with "equal or better" echocardiographic measurements (i.e., EA VTI measurements) with MPP feature on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm or MPP arm.\n\nAt the 9-month visit, responder status will be evaluated once again using the CCS and compared to the status at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s)\n* Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement\n* Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations\n\nExclusion Criteria:\n\n* Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment\n* Have an existing Class I recalled lead\n* Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate\n* Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months\n* Have permanent atrial fibrillation (AF)\n* Have undergone a cardiac transplantation within 40 days of enrollment\n* Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant.\n* Are currently participating in a clinical investigation that includes an active treatment arm\n* Are pregnant or planning to become pregnant during the duration of the study\n* Have a life expectancy of less than 9 months due to any condition\n* Are less than 18 years of age'}, 'identificationModule': {'nctId': 'NCT01786993', 'acronym': 'MPP IDE', 'briefTitle': 'MultiPoint Pacing IDE Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'MultiPoint Pacing IDE Study', 'orgStudyIdInfo': {'id': '60029161/D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-point pacing arm', 'description': 'MultiPoint Pacing', 'interventionNames': ['Device: MultiPoint Pacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biventricular arm', 'description': 'Traditional Biventricular Pacing', 'interventionNames': ['Device: Traditional Biventricular Pacing']}], 'interventions': [{'name': 'MultiPoint Pacing', 'type': 'DEVICE', 'description': 'Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.', 'armGroupLabels': ['Multi-point pacing arm']}, {'name': 'Traditional Biventricular Pacing', 'type': 'DEVICE', 'description': 'Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.', 'armGroupLabels': ['Biventricular arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research, LLC.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85027', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Heart Hospital', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Heart Hospital', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Memorial Hospital and Medical Center', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Green Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Premier Cardiology, Inc', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Regional Cardiology Associates', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Memorial Hospital', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Heart & Vascular, P.C.', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '06851', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Cardiology Associates of Fairfield County, PC', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Area Cardiology Associates PA', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Watson Clinic Center', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Memorial Hospital', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'HeartCare Midwest', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Baptist Hospital', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Thoracic Cardio Healthcare Foundation', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Jackson Heart Clinic', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Medical Center', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart and Lung Center', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Englewood Hospital and Medical Center', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Memorial Hospital', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico Heart Institute', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital/Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Heart and Vascular Research Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Medical Center Clinical Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43124', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Health Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Toledo Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '17602', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster General Hospital', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'WellSpan Health', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St. Thomas Hospital', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Heart and Vascular Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiology Center of Amarillo, L.L.P', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Heart', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78201', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Cardiovascular Consultants', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23454', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Cardiovascular Associates, LTD', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora Medical Group', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '54401', 'city': 'Wausau', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aspirus Wausau Hospital', 'geoPoint': {'lat': 44.95914, 'lon': -89.63012}}], 'overallOfficials': [{'name': 'Gery Tomassoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Baptist Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The study results will be presented at HRS Late-Breaking Clincial Trials Session in May, 2016'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}