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Completed

NCT Number: NCT04649788

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.

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Key information

Conditions

Pacemaker Implantable Cardioverter-defibrillator

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hopital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided axillary vein access

Device

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 access

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to venous access

    Time frame: Intervention time (day 0)

    Time from cutaneous incision to reach the right atrium with all needed guidewire using the assigned venous access technique

  2. Procedure duration

    Time frame: Intervention time (day 0)

    Time from cutaneous incision to skin suture

  3. Fluoroscopy time

    Time frame: Intervention time (day 0)

    Duration of fluoroscopy use during intervention

  4. X-Ray exposure

    Time frame: Intervention time (day 0)

    X-ray exposure during intervention, measured in mGycm2

  5. Complication

    Time frame: Intervention time (day 0)

    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.

  6. Cardiac implantable electronic device (CIED) related infection

    Time frame: Month 3

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Prospective Randomized Comparison of Efficacy and Safety of Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2020
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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