NCT04649788

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

August 26, 2025

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

October 15, 2020

Last Update Submit

August 20, 2025

Conditions

PacemakerImplantable Cardioverter-defibrillator

Keywords

pacemakerimplantable cardioverter-defibrillatoraxillary veincephalic veinultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Time to venous access

    Intervention time (day 0)

  • Procedure duration

    Intervention time (day 0)

  • Fluoroscopy time

    Intervention time (day 0)

  • X-Ray exposure

    Intervention time (day 0)

  • Complication

    Intervention time (day 0)

  • +1 more secondary outcomes

Study Arms (2)

Ultrasound-guided axillary vein access

ACTIVE COMPARATOR

This group of patients will receive the cardiac implantable electronic device with ultrasound-guided axillary venous access.

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.

Device: Cephalic vein access

Interventions

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.

Ultrasound-guided axillary vein access
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.

Cephalic vein access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

  • 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.

    PMID: 37832512RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

December 2, 2020

Study Start

July 17, 2020

Primary Completion

July 15, 2022

Study Completion

November 25, 2022

Last Updated

August 26, 2025

Record last verified: 2023-02

Locations

FR(1)