Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-05 @ 10:13 AM
Study NCT ID:
NCT02914457
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)
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': 'richard.cornelussen@medtronic.com', 'phone': '+31433566651', 'title': 'Richard Cornelussen', 'organization': 'Medtronic Bakken Research Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from enrollment to study exit. Follow-up time (enrollment to exit) for subjects varied from 1 to 113 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Enrolled Subjects', 'description': 'All patients that signed informed consent will be summarized', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 2, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Cardiac vein dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Lead dislogdement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrophysiological Study', 'description': 'Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.\n\nElectrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.'}], 'classes': [{'title': 'BiV apical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.59', 'spread': '2.56', 'groupId': 'OG000'}]}]}, {'title': 'BiV mid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.20', 'spread': '2.06', 'groupId': 'OG000'}]}]}, {'title': 'BiV basal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.51', 'spread': '2.15', 'groupId': 'OG000'}]}]}, {'title': 'Multispot simultaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.64', 'spread': '3.31', 'groupId': 'OG000'}]}]}, {'title': 'Multispot sequential', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.80', 'spread': '2.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'LV dP/dt max is a measurement of the initial velocity of myocardial contraction and is derivative of the LV-pressure. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\\[median dP/dt max during pacing On\\] - (median baseline dP/dt max during pacing Off\\])/\\[median dP/dt max during pacing Off\\]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.', 'unitOfMeasure': '% change LV dP/dt max', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population contains all subjects who completed electrophysiological study with analyzable data. For some patients not all pacing configurations were applied. Two patients missed Multispot sequential pacing and one patient missed BiV mid pacing.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrophysiological Study', 'description': 'Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.\n\nElectrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.'}], 'classes': [{'title': 'Correlation between % change LV dP/dt max and SBP', 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '0.54'}]}]}, {'title': 'Correlation between % change LV dP/dt max and DBP', 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.40'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'Measured by invasive arterial blood line connected to a sensitive membrane displacement sensor. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected.The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\\[median pressure during pacing On\\] - (median pressure during pacing Off\\])/\\[median pressure during pacing Off\\]. Correlation will be summarized over all pacing configurations and time points since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration or per time point. The general linear model as described in Blank \\& Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation.', 'unitOfMeasure': 'Correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with analyzable LV dP/dt max data and analyzable and/or available blood pressure data. Two patients of the 25 patients with analyzable LV dP/dt max data did not have blood pressure data available or analyzable.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Percentage Change LV dP/dt Max and Percentage Change Non-Invasive Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrophysiological Study', 'description': 'Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.\n\nElectrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.'}], 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'Acquired through finger volume clamp', 'reportingStatus': 'POSTED', 'populationDescription': 'The collection of non-invasive blood pressures was optional. During study execution, it was decided to not collect and/or analyze any non-invasive blood pressures.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Percentage Change LV dP/dt Max and Q-LV Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrophysiological Study', 'description': 'Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.\n\nElectrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.44'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'Derived from intra-cardiac leads (invasive) and surface electrodes (non-invasive) respectively. The Q-LV interval is defined as the time from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV electrogram (EGM) during a cardiac cycle. The Q-LV ratio will be calculated as Q-LV/QRS duration. Correlation will be summarized over all pacing configurations since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration. The general linear model as described in Blank \\& Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation between % change LV dP/dt max and Q-LV ratio.', 'unitOfMeasure': 'Correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population contains all subjects who completed electrophysiological study with analyzable data. For five patients no Q-LV timings were available for analysis.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Percentage Change LV dP/dt Max and % Change QRS Width', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrophysiological Study', 'description': 'Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.\n\nElectrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'groupId': 'OG000', 'lowerLimit': '-0.44', 'upperLimit': '-0.10'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'Derived from surface electrodes (non-invasive). The percentage change is determined as (\\[QRS width during pacing On\\] - (QRS width during pacing Off\\])/\\[QRS width during pacing Off\\]. The correlation between % change LV dP/dt max and % change QRS width will be summarized over all pacing configurations since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration or per time point. The general linear model as described in Blank \\& Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation.', 'unitOfMeasure': 'Correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population contains all subjects who completed electrophysiological study with analyzable data. For one patient no QRS width was available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electrophysiological Study', 'description': 'Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.\n\nElectrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects who completed electrophysiological study with analyzable data', 'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No veins available for lead placement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Electrical instability of patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'ECG acquisition error due to sweating', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Electrophysiological Study', 'description': 'Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.\n\nElectrophysiological Study: Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66.4', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled patient except patient with protocol deviation (subject was not eligible for study)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-30', 'size': 651207, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-20T02:48', 'hasProtocol': False}, {'date': '2015-10-22', 'size': 1626055, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-24T09:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2016-06-08', 'resultsFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-03', 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec)', 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'LV dP/dt max is a measurement of the initial velocity of myocardial contraction and is derivative of the LV-pressure. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\\[median dP/dt max during pacing On\\] - (median baseline dP/dt max during pacing Off\\])/\\[median dP/dt max during pacing Off\\]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure', 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'Measured by invasive arterial blood line connected to a sensitive membrane displacement sensor. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected.The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\\[median pressure during pacing On\\] - (median pressure during pacing Off\\])/\\[median pressure during pacing Off\\]. Correlation will be summarized over all pacing configurations and time points since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration or per time point. The general linear model as described in Blank \\& Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation.'}, {'measure': 'Correlation Between Percentage Change LV dP/dt Max and Percentage Change Non-Invasive Blood Pressure', 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'Acquired through finger volume clamp'}, {'measure': 'Correlation Between Percentage Change LV dP/dt Max and Q-LV Ratio', 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'Derived from intra-cardiac leads (invasive) and surface electrodes (non-invasive) respectively. The Q-LV interval is defined as the time from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV electrogram (EGM) during a cardiac cycle. The Q-LV ratio will be calculated as Q-LV/QRS duration. Correlation will be summarized over all pacing configurations since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration. The general linear model as described in Blank \\& Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation between % change LV dP/dt max and Q-LV ratio.'}, {'measure': 'Correlation Between Percentage Change LV dP/dt Max and % Change QRS Width', 'timeFrame': 'Participants were followed for the time of the EP procedure, which had a median duration of 48 min', 'description': 'Derived from surface electrodes (non-invasive). The percentage change is determined as (\\[QRS width during pacing On\\] - (QRS width during pacing Off\\])/\\[QRS width during pacing Off\\]. The correlation between % change LV dP/dt max and % change QRS width will be summarized over all pacing configurations since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration or per time point. The general linear model as described in Blank \\& Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '35647062', 'type': 'DERIVED', 'citation': 'Sterlinski M, Zakrzewska-Koperska J, Maciag A, Sokal A, Osca-Asensi J, Wang L, Spyropoulou V, Maus B, Lemme F, Okafor O, Stegemann B, Cornelussen R, Leyva F. Acute Hemodynamic Effects of Simultaneous and Sequential Multi-Point Pacing in Heart Failure Patients With an Expected Higher Rate of Sub-response to Cardiac Resynchronization Therapy: Results of Multicenter SYNSEQ Study. Front Cardiovasc Med. 2022 May 12;9:901267. doi: 10.3389/fcvm.2022.901267. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by MultiSpot LV pacing (either simultaneously or sequentially) in comparison to the response achieved by the current (standard) BiV pacing configuration in patients indicated/recommended for cardiac resynchronization therapy.', 'detailedDescription': 'The following pacing configurations will be evaluated.\n\nBiventricular pacing (BiV):\n\nPacing will be performed on one LV electrode pair, (at 3 different longitudinal locations), and on the tip of the RV-lead. In total, three different pacing BiV settings will be evaluated. Configuration 1: RV + LV lateral Apex, Configuration 2: RV + LV lateral Mid, Configuration 3: RV + LV lateral Base (Reference: Standard CRT)\n\nMultiSpot simultaneous LV-ventricular pacing (MultiSpot-SYN):\n\nPacing will be performed on 3 electrodes on the LV wall, placed at different longitudinal locations, and on the tip of the RV-lead simultaneously. Configuration 4: RV + LV lateral Apex + LV lateral Mid + LV lateral Base\n\nMultiSpot sequential LV-ventricular pacing (MultiSpot-SEQ):\n\n3 electrodes on the LV wall will be paced sequentially. The RV electrode will be paced simultaneously with last paced LV electrode.The timing-sequence and the amount of spots will depend on the electrical delays measured during the experiments. Configuration 5: LV lateral Apex =\\> LV lateral Mid =\\> LV lateral Base + RV'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is indicated or recommended for CRT-P or CRT-D device according to current applicable ESC/AHA guidelines\n* Subject is in sinus rhythm\n* Subject receives optimal heart failure oral medical therapy\n* Subject is willing to sign the informed consent form\n* Subject is 18 years or older\n\nExclusion Criteria:\n\n* Subject has permanent atrial fibrillation/flutter or tachycardia\n* Subject has pure right bundle branch block (= no additional left ventricular conduction delays)\n* Subject has left bundle branch block and QRS-duration of \\> 150 ms and no sign of myocardial scar indicated by late gadolinium enhancement MRI\n* Subject experienced recent myocardial infarction, within 40 days prior to enrollment\n* Subject underwent valve surgery, within 90 days prior to enrollment\n* Subject is post heart transplantation, or is actively listed on the transplantation list\n* Subject is implanted with a left ventricular assist device\n* Subject has severe renal disease (up to physicians discretion)\n* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)\n* Subject has severe aortic stenosis (with a valve area of \\<1.0 cm2 or significant valve disease expected to be operated within study period)\n* Subject has complex and uncorrected congenital heart disease\n* Subject has a mechanical heart valve\n* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control\n* Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager'}, 'identificationModule': {'nctId': 'NCT02914457', 'acronym': 'SYNSEQ', 'briefTitle': 'Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for CRT', 'orgStudyIdInfo': {'id': 'SYNSEQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrophysiological Study', 'description': 'Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.', 'interventionNames': ['Procedure: Electrophysiological Study']}], 'interventions': [{'name': 'Electrophysiological Study', 'type': 'PROCEDURE', 'description': 'Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.', 'armGroupLabels': ['Electrophysiological Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'country': 'Poland', 'facility': 'Klinika Choroby Wieńcowej', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Zabrze', 'country': 'Poland', 'facility': 'Medical University of Silesia, Silesian Center for Heart Disease,', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH)', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Košice', 'country': 'Slovakia', 'facility': 'Východoslovenský ústav srdcových a cievnych chorôb, a.s. (VUSCH)', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari I Politècnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Medical Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}