Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04958369 |
| Other study ID # |
93/01.03.2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
October 30, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
University Hospital of Patras |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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:
A. ultrasound-guided axillary venous access B. cephalic venous access through the cut-down
technique In case of access failure in Group A, the alternative puncture options are through
the cephalic vein, the axillary vein with angiography guidance, the axillary vein without
angiography guidance or the subclavian vein. In case of access failure in Group B which
includes the insertion of only one lead wire or none, the alternative puncture options are
through the axillary vein with angiography, the axillary vein without angiopraghy or the
subclavian vein.
Data of the study participants that will be recorded include: demographics, Body Mass Index
(BMI), cardiovascular risk factors, comorbidities, indication for cardiac device
implantation, type of device (pacemaker/defibrillator, single-chamber/dual-chamber), side of
implantation (right, left), type of pocket (subcutaneous, submuscular).
Regarding NOAC administration, patients will undergo the implantation procedure after
cessation of rivaroxaban for at least 20 hours before the procedure and apixaban or
dabigatran for at least 16 hours before the procedure. Longer periods of cessation will be
applied in patients with renal dysfunction. In patients on treatment with acenocoumarol or
warfarin, procedures will be performed without discontinuation of the drugs with target
INR=2.
Regarding anticoagulation management in patients with mechanical valves the following
anticoagulation management plan will be applied: i) in patients with metallic aortic valve,
no discontinuation of anticoagulation with target INR=2 and ii) in patients with metallic
mitral valve, no discontinuation of anticoagulation, with target INR<3-4.
The study hypothesis is that ultrasound-guided axillary venous access will lead to a higher
rate of successful implantation procedures compared to cephalic vein access through the
cut-down technique.
Based on available research data and pilot data, the hypothesis is that the success rate in
ultrasound-guided axillary venous access group will be 90% compared to 65% in the cephalic
venous access group. A sample size of 57 patients in each group is expected to offer
statistic power of 90% (a=0.05, two-tailed) to the aforementioned result.
The study has been approved by the Ethics Committee of the University Hospital of Patras. All
candidates will participate after written informed consent.
