Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02909868
Status:
UNKNOWN
Last Update Posted:
2023-01-10
First Post:
2016-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CS-03 Pressure-Volume Loop Sub-study With RV Lead Positioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2016-09-13', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the LV volumes (ml)', 'timeFrame': 'up to 2 hr', 'description': 'LV volume will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF'}, {'measure': 'Change in the LV pressures (mmHg)', 'timeFrame': 'up to 2 hr', 'description': 'LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF'}], 'secondaryOutcomes': [{'measure': 'Change in the pressure-volume ratio', 'timeFrame': 'up to 2 hr', 'description': 'LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '11738311', 'type': 'BACKGROUND', 'citation': 'Chen CH, Fetics B, Nevo E, Rochitte CE, Chiou KR, Ding PA, Kawaguchi M, Kass DA. Noninvasive single-beat determination of left ventricular end-systolic elastance in humans. J Am Coll Cardiol. 2001 Dec;38(7):2028-34. doi: 10.1016/s0735-1097(01)01651-5.'}, {'pmid': '17853871', 'type': 'BACKGROUND', 'citation': 'Klotz S, Dickstein ML, Burkhoff D. A computational method of prediction of the end-diastolic pressure-volume relationship by single beat. Nat Protoc. 2007;2(9):2152-8. doi: 10.1038/nprot.2007.270.'}]}, 'descriptionModule': {'briefSummary': 'The position of the RV lead may have an important role in the effectiveness of the Programmable Hypertension Control (PHC) therapy by the Moderato pacemaker eliciting a lag from which RV signals (QRS) are identified.\n\nThe study attempts to measure RV Pressure and RV Volume with PHC in two RV lead locations.', 'detailedDescription': 'Subjects found eligible for participation in the CS-03 study, who are indicated for a de novo pulse generator implant at the center participating in this sub-study and who are not 100% dependent on RV pacing are eligible for participation in this sub-study.\n\nPatients receiving a pacemaker pulse generator exchange or who are 100% pacemaker dependent may not participate.\n\nEligible patients will be provided with an Informed Consent specific to this sub-study and if patients choose to participate, patients will be asked to sign the Informed Consent and will then undergo the procedures described below.\n\nPatients will be prepared and draped for the Moderato implant procedure as detailed in the main CS-03 study protocol.\n\nSubjects will be instrumented prior to the Moderato Pacemaker implant procedure.\n\nThe position of the RV lead will be tested at two sites known to elicit shortest QRS duration (The RV apical septum and the His region).\n\nA series of three test periods with the Moderato System programmed to deliver predetermined PHC settings will follow.\n\nFollowing the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject was included in the CS-03 study\n* Subject indicated for a de novo pulse generator implant\n\nExclusion Criteria:\n\n* Subject was excluded from the CS-03 study\n* Subject is not 100% dependent on RV pacing\n* Subject receiving a pacemaker pulse generator exchange\n* Subject is unwilling or cannot provide Informed Consent for this sub study'}, 'identificationModule': {'nctId': 'NCT02909868', 'briefTitle': 'CS-03 Pressure-Volume Loop Sub-study With RV Lead Positioning', 'organization': {'class': 'INDUSTRY', 'fullName': 'BackBeat Medical Inc'}, 'officialTitle': 'Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial - PV Loops Sub-study', 'orgStudyIdInfo': {'id': 'CS-03 PV Loop substudy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RV location', 'description': "All included subjects will undergo the PV loop test with 'BackBeat PHC' ON and OFF", 'interventionNames': ['Device: BackBeat-PHC']}], 'interventions': [{'name': 'BackBeat-PHC', 'type': 'DEVICE', 'description': 'A conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure.', 'armGroupLabels': ['RV location']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'Na Homolce Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Petr Neuzil, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Na Homolce Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BackBeat Medical Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}