Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT03750058
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2018-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LV Multizone pacing success rate', 'timeFrame': '20 min', 'description': 'Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms'}, {'measure': 'LV pacing success rate', 'timeFrame': '20 min', 'description': 'Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms'}], 'secondaryOutcomes': [{'measure': 'Implant testing Procedure-related Adverse Events procedure.', 'timeFrame': '1 month post testing'}, {'measure': 'Electrical performance of device (1)', 'timeFrame': '20 min', 'description': 'Electrical performance focusing on LV pacing threshold (Volts)'}, {'measure': 'Electrical performance of device (2)', 'timeFrame': '20 min', 'description': 'Electrical performance focusing on LV pacing impedance (Ohm)'}, {'measure': 'Lead Implant Efficiency', 'timeFrame': '20 min', 'description': 'procedure time for successful placement'}, {'measure': 'Lead Implant Efficiency', 'timeFrame': '20 min', 'description': 'Radiation dose during implant'}, {'measure': 'Satisfaction of implanter', 'timeFrame': '20 min', 'description': 'handling assessment of implanter using satisfaction scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quadripolar LV leads'], 'conditions': ['Cardiac Resynchronisation Therapy']}, 'descriptionModule': {'briefSummary': 'Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient aged ≥18 years old.\n* Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines .\n* Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).\n* Signed and dated informed consent.\n* Patient affiliated with, or beneficiary of a social security category.\n\nExclusion Criteria:\n\n* Class IV of NYHA (ambulatory or not).\n* Allergy to contrast media used for imaging during cardiac catheterization.\n* Severe Renal Failure (clearance of creatinine \\< 30ml/mn/m²).\n* Previous failure catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.\n* Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.\n* Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).\n* Known pregnancy, breastfeeding women or in childbearing age without an adequate contraceptive method (failure rate \\< 1%).'}, 'identificationModule': {'nctId': 'NCT03750058', 'acronym': 'AXONE-Acute', 'briefTitle': 'Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy', 'orgStudyIdInfo': {'id': '2017/170/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implant test procedure', 'description': 'Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy', 'interventionNames': ['Device: Implant test procedure']}], 'interventions': [{'name': 'Implant test procedure', 'type': 'DEVICE', 'description': 'Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy', 'armGroupLabels': ['Implant test procedure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'country': 'France', 'facility': 'Lille University Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Frédéric ANSELME, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'collaborators': [{'name': 'MicroPort CRM', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}