Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 4:14 PM
Study NCT ID:
NCT04867460
Status:
TERMINATED
Last Update Posted:
2025-03-04
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054537', 'term': 'Atrioventricular Block'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'Recruitment too slow. Unrealistic to finish study with full recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean time to complete venous access', 'timeFrame': 'Peroperatively', 'description': 'Time from start of vascular access attempt to achieved access for the required number access points (ie number of leads)'}], 'secondaryOutcomes': [{'measure': 'Mean time to first venous access', 'timeFrame': 'Peroperatively', 'description': 'Time from start of vascular access attempt to achieved access for the first introducer or lead'}, {'measure': 'Successrate for full venous access', 'timeFrame': 'Peroperatively', 'description': 'Percentage of cases with achieved full venous access using the assigned technique, without having to change technique'}, {'measure': 'Successrate for full venous access within 3 minutes', 'timeFrame': 'Peroperatively', 'description': 'Percentage of cases with achieved full venous access within 3 minutes, using the assigned technique, without having to change technique'}, {'measure': 'Full venous access without any complication', 'timeFrame': 'Peroperatively within 24 hours', 'description': 'Percentage of full venous access without any complication (including arterial puncture, pneumothorax, hemothorax, local hematoma and other acute complications)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pacemaker', 'Implantable defibrillator', 'Venous access', 'Ultrasound'], 'conditions': ['Cardiac Arrhythmia', 'Heart Failure', 'AV Block']}, 'descriptionModule': {'briefSummary': 'The study will include patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. A 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (Siemens Freestyle). Primary outcome is mean time to vascular access. In addition, success rate, complication rate and total procedure time will be measured.', 'detailedDescription': 'Pacemaker- and defibrillator lead implants typically involve vascular access via the left cephalic, axillar or subclavian vein. Gaining access is usually straight forward for an experienced surgeon/implanter, but can be difficult in a minority of cases, or for implanters with less experience. Complications include arterial puncture, pneumothorax and local bleeding or hematoma. Traditionally cephalic vein cut-down is the first choice, but is only available in 70% of cases, and for more complex procedures involving three electrodes, an additional access is always required.\n\nUltrasound guidance is very common in other vascular access areas such as femoral artery, radial artery and internal jugular vein, but has not gained widespread acceptance in pacemaker procedures. High quality studies, demonstrating superiority or non-inferiority over other access methods are lacking.\n\nThe present study will include all comer patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. A 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (Siemens Freestyle). Implanters with various degrees of ultrasound experience and pacemaker surgery experience will participate in the study. All implanters will receive a 2-hour training lecture and additional hands-on training for the first 3 cases, by an ultrasound-experienced anaesthesiologist.\n\nAccess time and success rate will be recorded, and all acute complications will be recorded. Primary outcome is mean time to vascular access. In addition, success rate, complication rate and total procedure time will be measured. Outcome data will be analyzed for the entire cohort, but also stratified for implanter and excluding the first 10 cases for each implanter, to compensate for various experience and individual learning curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned pacemaker or implantable defibrillator surgery with at least one new transvenously placed lead.\n\nExclusion Criteria:\n\n* Difficult vascular access known before surgery, where special access technique is planned or required.'}, 'identificationModule': {'nctId': 'NCT04867460', 'acronym': 'TUFF', 'briefTitle': 'Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Ultrasound-guided Venous Access, Using a Wireless Probe, for Pacemaker and Defibrillator Implants - a Randomized Study', 'orgStudyIdInfo': {'id': 'TUFF-study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound guided venous access', 'description': 'Vascular access of the axillary vein will be performed using an ultrasound system (Siemens Acuson Freestyle) with a wireless vascular ultrasound probe (L8-3 or L13-5). One or more vascular punctures will be performed, as needed.', 'interventionNames': ['Procedure: Ultrasound guided venous access']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Vascular access of the axillary or subclavian vein will be performed using anatomical landmarks, fluoroscopy and/or injection of X-ray contrast in the antecubital vein, at the choice of the implanter. One or more vascular punctures will be performed, as needed.'}], 'interventions': [{'name': 'Ultrasound guided venous access', 'type': 'PROCEDURE', 'description': 'Access of the axillary vein using ultrasound guidance.', 'armGroupLabels': ['Ultrasound guided venous access']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'country': 'Sweden', 'facility': 'Skane University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}