Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices.

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.

Study Overview

• Status: Completed
• Conditions: Pacemaker; Implantable Cardioverter-defibrillator
• Intervention / Treatment: Device: Ultrasound-guided axillary vein access; Device: Cephalic vein access

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon - Hôpital de la Croix Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older
• Indication for endovenous pacemaker or cardioverter-defibrillator (single or double room)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound-guided axillary vein access; This group of patients will receive the cardiac implantable electronic device with ultrasound-guided axillary venous access.	Device: Ultrasound-guided axillary vein access; 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.
Active Comparator: Cephalic vein access; This group of patients will receive the cardiac implantable electronic device with cephalic venous access.	Device: Cephalic vein access; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intervention time (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to venous access	Time from cutaneous incision to reach the right atrium with all needed guidewire using the assigned venous access technique	Intervention time (day 0)
Procedure duration	Time from cutaneous incision to skin suture	Intervention time (day 0)
Fluoroscopy time	Duration of fluoroscopy use during intervention	Intervention time (day 0)
X-Ray exposure	X-ray exposure during intervention, measured in mGycm2	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.	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.	Month 3

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): November 25, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; pacemaker; axillary vein; implantable cardioverter-defibrillator; cephalic vein
• Other Study ID Numbers: 69HCL19_0540; ANSM (Other Identifier: 2026-A00172-49)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No