PacemakerNCT04649788
Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices.
A study testing Ultrasound-guided axillary vein access and Cephalic vein access in people with Pacemaker and Implantable Cardioverter-defibrillator, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe. Ultrasound-guided axillary vein access is a promising alternative but there is a lack of clinical evidence supporting this technique. 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 vein access and Cephalic vein access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2020to 25 Nov 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
- 18 years or older
- Indication for endovenous pacemaker or cardioverter-defibrillator (single or double room)
Who cannot join
- History of previously implanted endocardial lead
- Indication for cardiac resynchronization therapy
- Impossibility of venous access
- Unable/unwilling to provide informed consent
- Pregnant or breastfeeding woman
- Participating in another clinical study which can interfere with this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Comparison of Efficacy and Safety of Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices
Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe. Ultrasound-guided axillary vein access is a promising alternative but there is a lack of clinical evidence supporting this technique.
The purpose of this study is to compare the efficacy and safety of ultrasound-guided axillary vein access versus cephalic venous cutdown for implantation of endovenous CIED.
Half of patients is implanted using an ultrasound-guided axillary vein puncture. The other half is implanted using a cephalic vein cutdown. After venous access is achieved, implantation procedure is identical in the two arms.
- Conditions
- Pacemaker, Implantable Cardioverter-defibrillator
- Being tested
- Ultrasound-guided axillary vein access, Cephalic vein access
- Keywords
- pacemaker, implantable cardioverter-defibrillator, axillary vein, cephalic vein, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided axillary vein accessDevice
Venous access is performed through ultrasound-guided axillary vein puncture and Seldinger technique. After venous access is obtained, a guide-wire is advanced through the access needle, and the tip of the guide-wire is positioned in the right cardiac atrium.
Cephalic vein accessDevice
Venous access is performed through a cephalic vein cutdown approach. After venous access is obtained, a guide-wire is advanced and the tip of the guide-wire is positioned in the right cardiac atrium.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided axillary vein access | Active comparator | This group of patients will receive the cardiac implantable electronic device with ultrasound-guided axillary venous access. Receives: Device: Ultrasound-guided axillary vein access |
| Cephalic vein access | Active comparator | This group of patients will receive the cardiac implantable electronic device with cephalic venous access. Receives: Device: Cephalic vein access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of venous access
This outcome is measured by the operator during the intervention. It is the ability to successfully cannulate the vein and have all needed guidewire in the right atrium using the assigned venous access technique.
The outcome is a binary value: success or failure.
Measured: Intervention time (day 0)
Secondary outcomes (6)
Time to venous access
Time from cutaneous incision to reach the right atrium with all needed guidewire using the assigned venous access technique
Measured: Intervention time (day 0)
Procedure duration
Time from cutaneous incision to skin suture
Measured: Intervention time (day 0)
Fluoroscopy time
Duration of fluoroscopy use during intervention
Measured: Intervention time (day 0)
X-Ray exposure
X-ray exposure during intervention, measured in mGycm2
Measured: Intervention time (day 0)
Complication
All implant related complications including brachial plexus palsy, major pocket hematoma (hematoma requiring evacuation or transfusion or prolonged hospitalization), pneumothorax, hemothorax, pericardial effusion, lead dislodgement, device infection, venous thrombosis.
Measured: Intervention time (day 0)
Cardiac implantable electronic device (CIED) related infection
Local and systemic signs of CIED related infection will be monitored during follow-up. The definition and classification of CIED related infection are based on the current guideline and expert consensus statement.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start17 Jul 2020
- Primary completion15 Jul 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PacemakerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649788
- Sponsor's protocol ID
- 69HCL19_0540
- Other IDs
- ANSM
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2020
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Charles P, Ditac G, Montoy M, Thenard T, Courand PY, Lantelme P, Harbaoui B, Fareh S. Intra-pocket ultrasound-guided axillary vein puncture vs. cephalic vein cutdown for cardiac electronic device implantation: the ACCESS trial. Eur Heart J. 2023 Dec 7;44(46):4847-4858. doi: 10.1093/eurheartj/ehad629.
PubMed 37832512
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Efficacy and Safety of Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices
- ClinicalTrials.gov ID
- NCT04649788
- Acronym / sponsor ID
- 69HCL19_0540
- Conditions
- Pacemaker, Implantable Cardioverter-defibrillator
- Keywords
- pacemaker, implantable cardioverter-defibrillator, axillary vein, cephalic vein, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 2 Dec 2020 (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.
Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe. Ultrasound-guided axillary vein access is a promising alternative but there is a lack of clinical evidence supporting this technique.
The purpose of this study is to compare the efficacy and safety of ultrasound-guided axillary vein access versus cephalic venous cutdown for implantation of endovenous CIED.
Half of patients is implanted using an ultrasound-guided axillary vein puncture. The other half is implanted using a cephalic vein cutdown. After venous access is achieved, implantation procedure is identical in the two arms.
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 vein access | Active comparator | Device: Ultrasound-guided axillary vein accessThis group of patients will receive the cardiac implantable electronic device with ultrasound-guided axillary venous access. |
| Cephalic vein access | Active comparator | Device: Cephalic vein accessThis group of patients will receive the cardiac implantable electronic device with cephalic venous access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Indication for endovenous pacemaker or cardioverter-defibrillator (single or double room)
Key exclusion criteria (6 listed)
- History of previously implanted endocardial lead
- Indication for cardiac resynchronization therapy
- Impossibility of venous access
- Unable/unwilling to provide informed consent
- Pregnant or breastfeeding woman
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 vein accessVenous access is performed through ultrasound-guided axillary vein puncture and Seldinger technique. After venous access is obtained, a guide-wire is advanced through the access needle, and the tip of the guide-wire is positioned in the right cardiac atrium. | Device | Ultrasound-guided axillary vein access |
| Cephalic vein accessVenous access is performed through a cephalic vein cutdown approach. After venous access is obtained, a guide-wire is advanced and the tip of the guide-wire is positioned in the right cardiac atrium. | Device | Cephalic vein access |
Primary outcome
Success of venous access
Time frame: Intervention time (day 0)
This outcome is measured by the operator during the intervention. It is the ability to successfully cannulate the vein and have all needed guidewire in the right atrium using the assigned venous access technique. The outcome is a binary value: success or failure.
6 secondary outcomes
Time to venous access
Time frame: Intervention time (day 0)
Procedure duration
Time frame: Intervention time (day 0)
Fluoroscopy time
Time frame: Intervention time (day 0)
X-Ray exposure
Time frame: Intervention time (day 0)
Complication
Time frame: Intervention time (day 0)
Cardiac implantable electronic device (CIED) related infection
Time frame: Month 3
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 26 Aug 2025.
- Results publication: PubMed 37832512Charles P, Ditac G, Montoy M, Thenard T, Courand PY, Lantelme P, Harbaoui B, Fareh S. Intra-pocket ultrasound-guided axillary vein puncture vs. cephalic vein cutdown for cardiac electronic device implantation: the ACCESS trial. Eur Heart J. 2023 Dec 7;44(46):4847-4858. doi: 10.1093/eurheartj/ehad629.
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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 vein access and Cephalic vein access in people with Pacemaker and Implantable Cardioverter-defibrillator, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 6 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 26 Aug 2025. 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 France. 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?
Success of venous access (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?
On the ClinicalTrials.gov record for NCT04649788, which also lists 1 linked publication.
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 26 Aug 2025.