Comparison of the Ultrasound-guided Axillary Vein Puncture With the Conventional Cephalic Vein Cut-down Technique for Implantation of Cardiac Devices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 114
- Locations
- 2
- Primary Endpoint
- Rate of successful cardiac device implantation
Study Overview
Brief Summary
The implantation of cardiac electronic devices is a common procedure in the Electrophysiology Laboratory. The most commonly used venous access sites are the cephalic, the axillary and the subclavian vein.
Studies comparing these options have been conducted in the past. Axillary venous access can be achieved either through axillary vein angiography or by ultrasound guidance. Nevertheless, appropriate training is required for the ultrasound-guided axillary puncture technique-as well as for the cephalic vein cutdown technique.
Data from randomized trials regarding direct comparison of the two methods in terms of efficacy and safety are very limited.
The purpose of the study is the comparison of the efficacy and safety of the ultrasound-guided axillary venous access technique versus the cephalic venous access using the cut-down technique in patients requiring intravenous cardiac device (single-chamber/dual-chamber pacemaker/defibrillator) implantation.
Detailed Description
This study is a single-center, randomized, clinical trial. Its purpose is the comparison of the ultrasound-guided axillary venous access technique versus the cephalic venous access using the cut-down technique in cardiac device implantation procedures. Prerequisite for starting patients' recruitment is that the operators have undergone a training phase in ultrasound-guided axillary vein puncture in the Interventional Radiology Laboratory and have completed at least 30 procedures. A GE V-scan device with a special linear transducer for vessel examination will be utilized for the ultrasound guidance. Micropuncture technique will be performed for venous access.
Eligibility criteria:
Inclusion criteria
- Age ≥ 18 years
- Indication for single- or dual-chamber pacemaker of defibrillator implantation
- Written informed consent Exclusion criteria
- Indication for biventricular pacemaker or defibrillator
- Upgrade in pacing or defibrillation system
After the operators' training phase, candidates for pacemaker or defibrillator (single- or dual-chamber) implantation who fulfill the inclusion criteria will be randomly assigned with 1:1 allocation to one of the Groups:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Indication for single- or dual-chamber pacemaker of defibrillator implantation
- •Written informed consent
Exclusion Criteria
- •Indication for biventricular pacemaker/defibrillator
- •Upgrade in pacing or defibrillation system
Outcomes
Primary Outcomes
Rate of successful cardiac device implantation
Time Frame: Intervention time (Day 0)
Secondary Outcomes
- Duration of lead insertion procedure(Intervention time (Day 0))
- Radiation dose(Intervention time (Day 0))
- Total procedure duration(Intervention time (Day 0))
- Procedure-related complication rate (pneumothorax, cardiac tamponade, pocket hematoma, lead displacement, fever, need for antibiotic treatment)(Day 0-30)
- Fluoroscopy time(Intervention time (Day 0))
- Pain associated with the procedure assessed by use of the visual analogue pain scale from 0 to 10 (0: no pain, 10: worse pain)(Day 1)
- Duration of hospitalization(Through study completion, an average of 1.5 year)
Investigators
Georgios Leventopoulos
Consultant Cardiologist
University Hospital of Patras