Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06298669
Status:
TERMINATED
Last Update Posted:
2024-12-10
First Post:
2024-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Biventricular Versus Right Ventricular Pacing
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': 'maya.guglin@rutgers.edu', 'phone': '9085968459', 'title': 'Maya Guglin', 'organization': 'Rutgers'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Biventricular Pacing Followed by Right Ventricular Pacing', 'description': "Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.\n\nBiventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.\n\nRight Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions.", 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6 Minute Walk Test Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biventricular Pacing Followed by Right Ventricular Pacing', 'description': "Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.\n\nBiventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.\n\nRight Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions."}], 'classes': [{'title': 'Baseline visit', 'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000'}]}]}, {'title': 'Three month visit', 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline visit; Three-month visit', 'description': 'The distance walked over 6 minutes was measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.', 'unitOfMeasure': 'meters', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EQ-5D-3L Quality of Life Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biventricular Pacing Followed by Right Ventricular Pacing', 'description': "Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.\n\nBiventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.\n\nRight Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.293', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline visit', 'description': "Quality of Life was measured using the EQ-5D-3L questionnaire. The EQ-5D-3L asks participants to rate the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated as either no problems (score of 1), some problems (score of 2), or extreme problems (score of 3). Higher scores indicating a poorer overall quality of life in these dimensions. Scores on the five dimensions are summarized to create an index score. The EQ-5D-3L index score is a numerical value that summarizes a person's health state on a scale from -0.594 to 1:\n\n* 1: Full health\n* 0 or less: Equivalent to being dead or worse than dead\n\nThe questionnaire was only completed at the baseline visit for the single participant on study.", 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum NT-PRO-BNP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biventricular Pacing Followed by Right Ventricular Pacing', 'description': "Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.\n\nBiventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.\n\nRight Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions."}], 'classes': [{'title': 'Baseline visit', 'categories': [{'measurements': [{'value': '470', 'groupId': 'OG000'}]}]}, {'title': 'Three-month visit', 'categories': [{'measurements': [{'value': '515', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline visit; Three-month visit', 'description': 'Serum levels of N-terminal pro-brain natriuretic peptide (NT-PRO-BNP) were measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.', 'unitOfMeasure': 'pg/mL', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biventricular Pacing Followed by Right Ventricular Pacing', 'description': "Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.\n\nBiventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.\n\nRight Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions."}, {'id': 'FG001', 'title': 'Right Ventricular Pacing Followed by Biventricular Pacing', 'description': "Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to RV-first will have their CRT device reprogrammed to RV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to BiV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.\n\nBiventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles."}], 'periods': [{'title': 'First Intervention (Three Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (Three Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Biventricular Pacing Followed by Right Ventricular Pacing', 'description': "Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.\n\nBiventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.\n\nRight Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Age is not reported for the single study participant to protect confidentiality.', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Study was terminated after only one participant was enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-17', 'size': 296222, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-11T17:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Coordinator support was lost', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2024-03-01', 'resultsFirstSubmitDate': '2024-11-15', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-15', 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 Minute Walk Test Performance', 'timeFrame': 'Baseline visit; Three-month visit', 'description': 'The distance walked over 6 minutes was measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.'}], 'secondaryOutcomes': [{'measure': 'EQ-5D-3L Quality of Life Score', 'timeFrame': 'Baseline visit', 'description': "Quality of Life was measured using the EQ-5D-3L questionnaire. The EQ-5D-3L asks participants to rate the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated as either no problems (score of 1), some problems (score of 2), or extreme problems (score of 3). Higher scores indicating a poorer overall quality of life in these dimensions. Scores on the five dimensions are summarized to create an index score. The EQ-5D-3L index score is a numerical value that summarizes a person's health state on a scale from -0.594 to 1:\n\n* 1: Full health\n* 0 or less: Equivalent to being dead or worse than dead\n\nThe questionnaire was only completed at the baseline visit for the single participant on study."}, {'measure': 'Serum NT-PRO-BNP', 'timeFrame': 'Baseline visit; Three-month visit', 'description': 'Serum levels of N-terminal pro-brain natriuretic peptide (NT-PRO-BNP) were measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Left Ventricular Assist Device (LVAD)', 'Cardiac resynchronization therapy (CRT)'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test.', 'detailedDescription': "Heart failure patients with reduced left ventricular systolic function and worsening clinical status are frequently treated with mechanical devices. Cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVAD) are mainstays of advanced heart failure treatment and have independently been demonstrated to decrease mortality. However, minimal research documents the utility of these two modalities in unison. There have been recent investigations comparing Biventricular (BiV) versus right ventricular (RV) pacing suggesting better exercise performance and decreased left ventricular (LV) volumes with RV pacing. This discovery contrasts with prior meta-analysis that reports no difference between LVAD patients with and without CRT including mortality and hospitalizations. Investigators aim to compare BiV pacing and RV pacing in LVAD patients with CRT on patient's exercise tolerance and frequency of tachyarrhythmias. Additionally, research is required to form a conclusion on the role of CRT in LVAD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with both an LVAD and CRT device with functional leads\n* Age 18 years and older\n* Ability to walk\n* Ability to sign consent\n\nExclusion Criteria:\n\n* Patients with permanent atrial fibrillation\n* Patients who are pacemaker dependent\n* Patients with sustained ventricular tachycardia'}, 'identificationModule': {'nctId': 'NCT06298669', 'briefTitle': 'Biventricular Versus Right Ventricular Pacing', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Selection of Cardiac Resynchronization Therapy Pacing Modalities in Patients Supported by LVADs', 'orgStudyIdInfo': {'id': '16052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biventricular Pacing followed by Right Ventricular Pacing', 'description': "Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.", 'interventionNames': ['Device: Biventricular Pacing', 'Device: Right Ventricular Pacing']}, {'type': 'EXPERIMENTAL', 'label': 'Right Ventricular Pacing followed by Biventricular Pacing', 'description': "Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to RV-first will have their CRT device reprogrammed to RV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to BiV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.", 'interventionNames': ['Device: Biventricular Pacing']}], 'interventions': [{'name': 'Biventricular Pacing', 'type': 'DEVICE', 'description': 'The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.', 'armGroupLabels': ['Biventricular Pacing followed by Right Ventricular Pacing', 'Right Ventricular Pacing followed by Biventricular Pacing']}, {'name': 'Right Ventricular Pacing', 'type': 'DEVICE', 'description': 'The CRT device will be reprogrammed for right ventricular contractions.', 'armGroupLabels': ['Biventricular Pacing followed by Right Ventricular Pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Medicine', 'investigatorFullName': 'Maya Guglin', 'investigatorAffiliation': 'Indiana University'}}}}