PacemakerNCT04958369
Ultrasound-guided Axillary Versus Conventional Cephalic Venous Access for Implantation of Cardiac Devices
A study testing Ultrasound-guided axillary venous access and Cephalic venous access in people with Pacemaker and Implantable Cardioverter-defibrillator, run by University Hospital of Patras at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Implantable Cardioverter-defibrillator
- What is being tested?
- Ultrasound-guided axillary venous access and Cephalic venous access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2021to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Indication for single- or dual-chamber pacemaker of defibrillator implantation
- Written informed consent
Who cannot join
- Indication for biventricular pacemaker/defibrillator
- Upgrade in pacing or defibrillation system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Ultrasound-guided Axillary Vein Puncture With the Conventional Cephalic Vein Cut-down Technique for Implantation of Cardiac Devices
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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Pacemaker, Implantable Cardioverter-defibrillator
- Being tested
- Ultrasound-guided axillary venous access, Cephalic venous access
- Keywords
- pacemaker, implantable cardioverter-defibrillator, axillary vein, cephalic vein, ulatraound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided axillary venous accessDevice
Venous access is obtained through ultrasound-guided axillary vein puncture and Seldinger technique.
Cephalic venous accessDevice
Venous access is obtained through cephalic vein cut-down.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided axillary venous access | Active comparator | Cardiac device implantation will be performed with ultrasound-guided axillary venous access. Receives: Device: Ultrasound-guided axillary venous access |
| Cephalic venous access | Active comparator | Cardiac device implantation will be performed with conventional cephalic venous access (cut-down technique). Receives: Device: Cephalic venous access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful cardiac device implantation
Measured: Intervention time (Day 0)
Secondary outcomes (7)
Duration of lead insertion procedure
Time from the administration of local anesthesia to the insertion of leads into the inferior vena cava
Measured: Intervention time (Day 0)
Total procedure duration
Time from the administration of local anesthesia to skin suture
Measured: Intervention time (Day 0)
Radiation dose
Measured: Intervention time (Day 0)
Fluoroscopy time
Measured: Intervention time (Day 0)
Procedure-related complication rate (pneumothorax, cardiac tamponade, pocket hematoma, lead displacement, fever, need for antibiotic treatment)
All procedure related complications including pneumothorax, cardiac tamponade, pocket hematoma, lead displacement, fever, need for antibiotic treatment
Measured: Day 0-30
Pain associated with the procedure assessed by use of the visual analogue pain scale from 0 to 10 (0: no pain, 10: worse pain)
Pain associated with the procedure assessed by use of the visual analogue pain scale from 0 to 10 (0: no pain, 10: worse pain)
Measured: Day 1
Duration of hospitalization
The number of days from the day of implantation till the day of hospital discharge
Measured: Through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 May 2021
- Primary completion30 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Leventopoulos, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958369
- Sponsor's protocol ID
- 93/01.03.2021
- Status last verified
- Oct 2022
- First submitted
- 27 Jun 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ultrasound-guided Axillary Vein Puncture With the Conventional Cephalic Vein Cut-down Technique for Implantation of Cardiac Devices
- ClinicalTrials.gov ID
- NCT04958369
- Acronym / sponsor ID
- 93/01.03.2021
- Conditions
- Pacemaker, Implantable Cardioverter-defibrillator
- Keywords
- pacemaker, implantable cardioverter-defibrillator, axillary vein, cephalic vein, ulatraound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided axillary venous access | Active comparator | Device: Ultrasound-guided axillary venous accessCardiac device implantation will be performed with ultrasound-guided axillary venous access. |
| Cephalic venous access | Active comparator | Device: Cephalic venous accessCardiac device implantation will be performed with conventional cephalic venous access (cut-down technique). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Indication for single- or dual-chamber pacemaker of defibrillator implantation
- Written informed consent
Key exclusion criteria (2 listed)
- Indication for biventricular pacemaker/defibrillator
- Upgrade in pacing or defibrillation system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided axillary venous accessVenous access is obtained through ultrasound-guided axillary vein puncture and Seldinger technique. | Device | Ultrasound-guided axillary venous access |
| Cephalic venous accessVenous access is obtained through cephalic vein cut-down. | Device | Cephalic venous access |
Primary outcome
Rate of successful cardiac device implantation
Time frame: Intervention time (Day 0)
7 secondary outcomes
Duration of lead insertion procedure
Time frame: Intervention time (Day 0)
Total procedure duration
Time frame: Intervention time (Day 0)
Radiation dose
Time frame: Intervention time (Day 0)
Fluoroscopy time
Time frame: Intervention time (Day 0)
Procedure-related complication rate (pneumothorax, cardiac tamponade, pocket hematoma, lead displacement, fever, need for antibiotic treatment)
Time frame: Day 0-30
Pain associated with the procedure assessed by use of the visual analogue pain scale from 0 to 10 (0: no pain, 10: worse pain)
Time frame: Day 1
Duration of hospitalization
Time frame: Through study completion, an average of 1.5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided axillary venous access and Cephalic venous access in people with Pacemaker and Implantable Cardioverter-defibrillator, run by University Hospital of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful cardiac device implantation (time frame: Intervention time (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.