Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05101720
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2021-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-05', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.', 'timeFrame': 'One month after index procedure', 'description': 'Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pacemaker', 'ICD', 'arrhythmias', 'Cardiac Implantable Electronic Device', 'Vascular access', 'Venous puncture', 'Ultrasound', 'Fluoroscopy'], 'conditions': ['Arrhythmias, Cardiac', 'Venous Puncture', 'Implantable Defibrillator User', 'Pacemaker Complication', 'Vascular Access Complication', 'Fluoroscopy; Adverse Effect']}, 'referencesModule': {'references': [{'pmid': '38243998', 'type': 'DERIVED', 'citation': 'Vitali F, Malagu M, Bianchi N, De Raffele M, Manfrini M, Gibiino F, Boccadoro A, Azzolini G, Balla C, Bertini M. Ultrasound-Guided Venous Axillary Access Versus Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI Randomized Trial. JACC Clin Electrophysiol. 2024 Mar;10(3):554-565. doi: 10.1016/j.jacep.2023.11.020. Epub 2024 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable cardioverter-defibrillator implantations.', 'detailedDescription': 'Rationale: axillary, cephalic and subclavian venous accesses are commonly used in pacemaker and implantable cardioverter defibrillator implantations. Axillary puncture and cephalic vein surgical cutdown are both recommended in international guidelines due to low risk of pneumothorax and chronic lead complications. Sometimes cephalic vein is not available. Today axillary puncture is performed under fluoroscopic view and some complications still exist with this venous access as pneumothorax and arterial puncture. Axillary vein direct visualization can be obtained with standard venography or with ultrasound. With direct visualization and puncture of the axillary vein under ultrasound guidance venography with radiocontrast could be avoided. Less radiation exposure for patient and operator and direct visualization of the needle are possible with lower periprocedural complications using ultrasound. Despite the great interest for ultrasound guided axillary puncture up today we have few data on its feasibility. Our hypothesis is that ultrasound guided axillary access is more safe and more feasible than the standard fluoroscopic technique.\n\nWe decided to enroll all the patients undergoing standard transvenous pacemaker or cardioverter implantable defibrillator. We randomize the patients with 1:1 fashion to axillary venous access under fluoroscopic guidance or to ultrasound guided axillary venous access.\n\nObiectives: to asses safety, feasibility of the ultrasound guided venous puncture.\n\nMain Endpoint: composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Leadless pacemaker or subcutaneous ICD'}, 'identificationModule': {'nctId': 'NCT05101720', 'acronym': 'ZEROFLUOROAXI', 'briefTitle': 'Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation', 'orgStudyIdInfo': {'id': 'CE-AVEC 555/2021/Sper/AOUFe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound Guided Axillary Access', 'description': 'Direct visualization of axillary vein with ultrasound will be obtained and used as a guidance for venous puncture.', 'interventionNames': ['Procedure: Ultrasound Guided Axillary Venous Access']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoroscopic Guided Axillary Access', 'description': 'Standard technique: using the intersection of the lateral borders of the second and third rib as a radiological landmarks.', 'interventionNames': ['Procedure: Fluoroscopy-Guided Axillary Venous Access']}], 'interventions': [{'name': 'Ultrasound Guided Axillary Venous Access', 'type': 'PROCEDURE', 'description': 'Direct visualization of axillary vein will be obtained with ultrasound sterile linear probe.', 'armGroupLabels': ['Ultrasound Guided Axillary Access']}, {'name': 'Fluoroscopy-Guided Axillary Venous Access', 'type': 'PROCEDURE', 'description': 'Fluoroscopic landmarks will be used and axillary venous puncture will be performed without ultrasound', 'armGroupLabels': ['Fluoroscopic Guided Axillary Access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}], 'overallOfficials': [{'name': 'Matteo Bertini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Ferrara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Professor', 'investigatorFullName': 'Matteo Bertini', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}