Primary Implantation of an Intracardiac Electronic Device IndicationPhase 3MultiPM-ACCESSNCT07273929
Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device
A Phase 3 study testing Intervention 1: Cephalic vein dissection, Intervention 2 : Percutaneous echo-guided axillary route and Intervention 3 : Intrapocket ultrasound-guided axillary route in people with Primary Implantation of an Intracardiac Electronic Device Indication, run by Hospices Civils de Lyon at 7 sites in France.
Trial summary
The implantation of an intra-cardiac electronic device (ICD) (pacemaker or defibrillator) is a frequent procedure, and one whose incidence is on the rise in the field of cardiology. In France in 2016, 69042 pacemakers and 8174 defibrillators were implanted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Implantation of an Intracardiac Electronic Device Indication
- What is being tested?
- Intervention 1: Cephalic vein dissection, Intervention 2 : Percutaneous echo-guided axillary route and Intervention 3 : Intrapocket ultrasound-guided axillary route
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Sep 2026to 1 Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- First implantation of a pacemaker or defibrillator (single or double chamber) or implantation of a lead in the left branch area in the case of a venticular lead.
- Informed consent signed by the patient
Who cannot join
- Implantation of an intra-cardiac triple-chamber electronic device (cardiac resynchronisation)
- Prior impossibility of venous access
- Pregnant, parturient or breast-feeding women
- Persons deprived of their liberty by judicial or administrative decision
- Persons under psychiatric care
- Persons admitted to a health or social establishment for purposes other than research
Show all 9Show fewer
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Patients participating in other research that may interfere with this study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Romain ESCHALIER, MD PhD
Hôpital F. MITTERRAND
Dijon, 21000
Lyon-Croix Rousse
Lyon, 69004
Ghoulem TABDJOUN, MD, 04 27 85 66 89 ext. +33, ghoulem.tabdjoun@chu-lyon.fr
Paul CHARLES, MD
Lyon-Louis Pradel
Lyon, 69500
Arnaud DULAC, MD
Hôpital privé Jacques Cartier
Massy, 91300
Laurent FIORINA, MD
CH Annexy-Genevois, site Annecy
Metz, 74000
Antoine DOMPNIER, MD
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42800
Antoine DA COSTA, MD PhD
About this study
Official title: Multicenter Randomised Controlled Trial: Benefit of Intra-pocket Echo-guided Axillary Puncture Compared With Percutaneous Echo-guided Axillary Puncture and Cephalic Vein Dissection for the Primary Implantation of Intracardiac Electronic Devices.
The implantation of an intra-cardiac electronic device (ICD) (pacemaker or defibrillator) is a frequent procedure, and one whose incidence is on the rise in the field of cardiology. In France in 2016, 69042 pacemakers and 8174 defibrillators were implanted.
The procedure involves inserting one or more intra-cardiac leads using venous access. Navigation in the heart chambers is guided by fluoroscopy. Each lead is connected to a box that is placed under the skin in the deltopectoral groove.
Read more
The venous vascular approach or venous access is a key stage. It can be time-consuming and a source of complications (haematoma, pneumothorax, nerve damage, catheter malfunction).
There are several methods of vascular access: cephalic vein dissection, subclavian vein puncture guided by anatomical landmarks, axillary puncture guided by scopy (X-rays) or intraoperative ultrasound.
The implantation of an intra-cardiac electronic device (ICD) (pacemaker or defibrillator) is a frequent procedure, and one whose incidence is on the rise in the field of cardiology. In France in 2016, 69042 pacemakers and 8174 defibrillators were implanted.
The procedure involves inserting one or more intra-cardiac leads using venous access. Navigation in the heart chambers is guided by fluoroscopy. Each lead is connected to a box that is placed under the skin in the deltopectoral groove.
The venous vascular approach or venous access is a key stage. It can be time-consuming and a source of complications (haematoma, pneumothorax, nerve damage, catheter malfunction).
There are several methods of vascular access: cephalic vein dissection, subclavian vein puncture guided by anatomical landmarks, axillary puncture guided by scopy (X-rays) or intraoperative ultrasound.
The most commonly used venous access for DEIC implantation in Europe today is cephalic vein dissection (60%). The subclavian vein is used in 21% of cases and the axillary vein in 19%.
There is currently no recommendation as to which technique should be used as first-line treatment.
The subclavian route is performed by puncture without direct visualisation of the vein, and therefore presents a risk of complications such as pneumothorax.
The cephalic route has few complications, but requires lengthy and tedious dissection and considerable experience. According to the literature, the failure rate is between 20 and 30%.
For axillary vein puncture, several options have been described: blind, scopy-guided with venography and ultrasound-guided.
Ultrasound-guided axillary puncture has been proposed for several years, but is currently not widely used. According to the literature, this technique seems to have a high success rate with a low complication rate, particularly with regard to the risk of pneumothorax. There are currently two ultrasound-guided axillary puncture techniques.
The 'intra-pocket' axillary puncture technique involves performing a puncture after making the incision using a special ultrasound probe (shaped like a golf club), placed in contact with the pectoral muscle.
Percutaneous" axillary puncture, on the other hand, is performed using a standard linear vascular ultrasound probe. Here the puncture is performed before the incision and the probe is placed in contact with the skin.
According to the literature currently available, the ultrasound-guided 'intra-pocket' technique appears to have a better success rate than the ultrasound-guided 'percutaneous' technique (95-99% success rate vs. 90-95%).
The investigators recently conducted the ACCESS study, a prospective, single-centre, randomised, open-label study comparing echo-guided 'intra-pocket' axillary puncture with the conventional cephalic vein dissection technique. the investigators demonstrated that this technique has a higher success rate than cephalic vein dissection, with a significant time saving (success rate: 99 vs. 87% (p=0.01), procedure time: 33.8 vs. 46.9 min,p= 0.005).
Our project is therefore to carry out a multicentre randomised trial to confirm these promising initial results and to assess the efficacy and safety of 'intra-pocket' echo-guided axillary venipuncture compared with 'percutaneous' echo-guided axillary venipuncture and the reference technique of cephalic dissection during implantation of a DEIC.
- Being tested
- Intervention 1: Cephalic vein dissection, Intervention 2 : Percutaneous echo-guided axillary route, Intervention 3 : Intrapocket ultrasound-guided axillary route
- Keywords
- venous access, intracardiac device, ryhthmology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: Cephalic vein dissectionProcedure or surgery
After an incision in the deltopectoral groove and careful dissection of the superficial fatty layer, the cephalic vein is revealed and separated from its tissue attachments over a distance of approximately 2 centimetres before being cannulated in order to introduce the necessary guides.
The electronic device will be fitted using the guides introduced in this way.
Intervention 2 : Percutaneous echo-guided axillary routeProcedure or surgery
A standard vascular linear ultrasound probe is placed in a single-use sterile sheath. The probe is brought into contact with the skin and we then perform a needle puncture of the vein under ultrasound control. Once the puncture or punctures have been successful, a guide is inserted into the vein and the incision is made after the puncture.
The electronic device will be fitted using the guides introduced in this way.
Intervention 3 : Intrapocket ultrasound-guided axillary routeProcedure or surgery
A special ultrasound probe (shaped like a hiccup) is placed in a single-use sterile sheath. After making an incision in the deltopectoral groove and dissecting the fatty layer, the probe is placed in contact with the pectoral muscle to visualise the axillary vein. Needle puncture of the vein is performed under ultrasound guidance. Once the puncture is successful, a guide is inserted into the vein.
The electronic device will be fitted using the guides introduced in this way.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Cephalic vein dissection | Experimental | After an incision in the deltopectoral groove and careful dissection of the superficial fatty layer, the cephalic vein is revealed and separated from its tissue attachments over a distance of approximately 2 centimetres before being cannulated in order to introduce the necessary guides.
The electronic device will be fitted using the guides introduced in this way. Receives: Procedure: Intervention 1: Cephalic vein dissection |
| Group 2 : Percutaneous echo-guided axillary route | Experimental | A standard vascular linear ultrasound probe is placed in a single-use sterile sheath. The probe is brought into contact with the skin and the investigators then perform a needle puncture of the vein under ultrasound control. Once the puncture or punctures have been successful, a guide is inserted into the vein and the incision is made after the puncture.
The electronic device will be fitted using the guides introduced in this way. Receives: Procedure: Intervention 2 : Percutaneous echo-guided axillary route |
| Group 3 : Intrapocket ultrasound-guided axillary route | Experimental | A special ultrasound probe (shaped like a hiccup) is placed in a single-use sterile sheath. After making an incision in the deltopectoral groove and dissecting the fatty layer, the probe is placed in contact with the pectoral muscle to visualise the axillary vein. Needle puncture of the vein is performed under ultrasound guidance. Once the puncture is successful, a guide is inserted into the vein. Receives: Procedure: Intervention 3 : Intrapocket ultrasound-guided axillary route |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rates of the three procedures
To assess the efficacy of echo-guided axillary puncture using the intra-pocket technique compared with the other 2 techniques in adult patients undergoing primary implantation of an intra-cardiac electronic device.
The three groups were compared on the binary criterion of failure/success of access directly during the procedure. The success of the vascular approach is defined by the success rate of insertion of all the leads using the first venous access technique assigned by randomisation.
Measured: During the intervention
Secondary outcomes (1)
Vascular access time
Comparison between groups of vascular access time (superior vena cava time) measured in seconds: Time between skin incision and presence of all necessary guides in the superior vena cava for the 'intra pocket' axillary group and cephalic vein dissection / Time between first puncture and presence of all necessary guides in the superior vena cava for the 'percutaneous' axillary group.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Implantation of an Intracardiac Electronic Device IndicationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
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
- NCT07273929
- Sponsor's protocol ID
- 69HCL24_0743
- Acronym
- MultiPM-ACCESS
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2025
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomised Controlled Trial: Benefit of Intra-pocket Echo-guided Axillary Puncture Compared With Percutaneous Echo-guided Axillary Puncture and Cephalic Vein Dissection for the Primary Implantation of Intracardiac Electronic Devices.
- ClinicalTrials.gov ID
- NCT07273929
- Acronym / sponsor ID
- MultiPM-ACCESS / 69HCL24_0743
- Keywords
- venous access, intracardiac device, ryhthmology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 10 Dec 2025 (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 an intra-cardiac electronic device (ICD) (pacemaker or defibrillator) is a frequent procedure, and one whose incidence is on the rise in the field of cardiology. In France in 2016, 69042 pacemakers and 8174 defibrillators were implanted.
The procedure involves inserting one or more intra-cardiac leads using venous access. Navigation in the heart chambers is guided by fluoroscopy. Each lead is connected to a box that is placed under the skin in the deltopectoral groove.
The venous vascular approach or venous access is a key stage. It can be time-consuming and a source of complications (haematoma, pneumothorax, nerve damage, catheter malfunction).
There are several methods of vascular access: cephalic vein dissection, subclavian vein puncture guided by anatomical landmarks, axillary puncture guided by scopy (X-rays) or intraoperative ultrasound.
The implantation of an intra-cardiac electronic device (ICD) (pacemaker or defibrillator) is a frequent procedure, and one whose incidence is on the rise in the field of cardiology. In France in 2016, 69042 pacemakers and 8174 defibrillators were implanted.
The procedure involves inserting one or more intra-cardiac leads using venous access. Navigation in the heart chambers is guided by fluoroscopy. Each lead is connected to a box that is placed under the skin in the deltopectoral groove.
The venous vascular approach or venous access is a key stage. It can be time-consuming and a source of complications (haematoma, pneumothorax, nerve damage, catheter malfunction).
There are several methods of vascular access: cephalic vein dissection, subclavian vein puncture guided by anatomical landmarks, axillary puncture guided by scopy (X-rays) or intraoperative ultrasound.
The most commonly used venous access for DEIC implantation in Europe today is cephalic vein dissection (60%). The subclavian vein is used in 21% of cases and the axillary vein in 19%.
There is currently no recommendation as to which technique should be used as first-line treatment.
The subclavian route is performed by puncture without direct visualisation of the vein, and therefore presents a risk of complications such as pneumothorax.
The cephalic route has few complications, but requires lengthy and tedious dissection and considerable experience. According to the literature, the failure rate is between 20 and 30%.
For axillary vein puncture, several options have been described: blind, scopy-guided with venography and ultrasound-guided.
Ultrasound-guided axillary puncture has been proposed for several years, but is currently not widely used. According to the literature, this technique seems to have a high success rate with a low complication rate, particularly with regard to the risk of pneumothorax. There are currently two ultrasound-guided axillary puncture techniques.
The 'intra-pocket' axillary puncture technique involves performing a puncture after making the incision using a special ultrasound probe (shaped like a golf club), placed in contact with the pectoral muscle.
Percutaneous" axillary puncture, on the other hand, is performed using a standard linear vascular ultrasound probe. Here the puncture is performed before the incision and the probe is placed in contact with the skin.
According to the literature currently available, the ultrasound-guided 'intra-pocket' technique appears to have a better success rate than the ultrasound-guided 'percutaneous' technique (95-99% success rate vs. 90-95%).
The investigators recently conducted the ACCESS study, a prospective, single-centre, randomised, open-label study comparing echo-guided 'intra-pocket' axillary puncture with the conventional cephalic vein dissection technique. the investigators demonstrated that this technique has a higher success rate than cephalic vein dissection, with a significant time saving (success rate: 99 vs. 87% (p=0.01), procedure time: 33.8 vs. 46.9 min,p= 0.005).
Our project is therefore to carry out a multicentre randomised trial to confirm these promising initial results and to assess the efficacy and safety of 'intra-pocket' echo-guided axillary venipuncture compared with 'percutaneous' echo-guided axillary venipuncture and the reference technique of cephalic dissection during implantation of a DEIC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multicenter randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Cephalic vein dissection | Experimental | Procedure: Intervention 1: Cephalic vein dissectionAfter an incision in the deltopectoral groove and careful dissection of the superficial fatty layer, the cephalic vein is revealed and separated from its tissue attachments over a distance of approximately 2 centimetres before being cannulated in order to introduce the necessary guides. The electronic device will be fitted using the guides introduced in this way. |
| Group 2 : Percutaneous echo-guided axillary route | Experimental | Procedure: Intervention 2 : Percutaneous echo-guided axillary routeA standard vascular linear ultrasound probe is placed in a single-use sterile sheath. The probe is brought into contact with the skin and the investigators then perform a needle puncture of the vein under ultrasound control. Once the puncture or punctures have been successful, a guide is inserted into the vein and the incision is made after the puncture. The electronic device will be fitted using the guides introduced in this way. |
| Group 3 : Intrapocket ultrasound-guided axillary route | Experimental | Procedure: Intervention 3 : Intrapocket ultrasound-guided axillary routeA special ultrasound probe (shaped like a hiccup) is placed in a single-use sterile sheath. After making an incision in the deltopectoral groove and dissecting the fatty layer, the probe is placed in contact with the pectoral muscle to visualise the axillary vein. Needle puncture of the vein is performed under ultrasound guidance. Once the puncture is successful, a guide is inserted into the vein. |
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
- First implantation of a pacemaker or defibrillator (single or double chamber) or implantation of a lead in the left branch area in the case of a venticular lead.
- Informed consent signed by the patient
Key exclusion criteria (9 listed)
- Implantation of an intra-cardiac triple-chamber electronic device (cardiac resynchronisation)
- Prior impossibility of venous access
- Pregnant, parturient or breast-feeding women
- Persons deprived of their liberty by judicial or administrative decision
- Persons under psychiatric care
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 |
|---|---|---|
| Intervention 1: Cephalic vein dissectionAfter an incision in the deltopectoral groove and careful dissection of the superficial fatty layer, the cephalic vein is revealed and separated from its tissue attachments over a distance of approximately 2 centimetres before being cannulated in order to introduce the necessary guides. The electronic device will be fitted using the guides introduced in this way. | Procedure or surgery | Group 1 : Cephalic vein dissection |
| Intervention 2 : Percutaneous echo-guided axillary routeA standard vascular linear ultrasound probe is placed in a single-use sterile sheath. The probe is brought into contact with the skin and we then perform a needle puncture of the vein under ultrasound control. Once the puncture or punctures have been successful, a guide is inserted into the vein and the incision is made after the puncture. The electronic device will be fitted using the guides introduced in this way. | Procedure or surgery | Group 2 : Percutaneous echo-guided axillary route |
| Intervention 3 : Intrapocket ultrasound-guided axillary routeA special ultrasound probe (shaped like a hiccup) is placed in a single-use sterile sheath. After making an incision in the deltopectoral groove and dissecting the fatty layer, the probe is placed in contact with the pectoral muscle to visualise the axillary vein. Needle puncture of the vein is performed under ultrasound guidance. Once the puncture is successful, a guide is inserted into the vein. The electronic device will be fitted using the guides introduced in this way. | Procedure or surgery | Group 3 : Intrapocket ultrasound-guided axillary route |
Primary outcome
Success rates of the three procedures
Time frame: During the intervention
To assess the efficacy of echo-guided axillary puncture using the intra-pocket technique compared with the other 2 techniques in adult patients undergoing primary implantation of an intra-cardiac electronic device. The three groups were compared on the binary criterion of failure/success of access directly during the procedure. The success of the vascular approach is defined by the success rate of insertion of all the leads using the first venous access technique assigned by randomisation.
1 secondary outcome
Vascular access time
Time frame: During the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intervention 1: Cephalic vein dissection, Intervention 2 : Percutaneous echo-guided axillary route and Intervention 3 : Intrapocket ultrasound-guided axillary route in people with Primary Implantation of an Intracardiac Electronic Device Indication, run by Hospices Civils de Lyon at 7 sites 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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul CHARLES, Dr (04 72 07 16 72 ext. +33, paul.charles@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rates of the three procedures (time frame: During the intervention). 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 27 Mar 2026.