MedTrace Logo

Ultrasound-guided Axillary Versus Conventional Cephalic Venous Access for Implantation of Cardiac Devices

NCT04958369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2022-11-01

No results posted yet for this study

Summary

The implantation of cardiac electronic devices is a common procedure in the Electrophysiology Laboratory. The most commonly used venous access sites are the cephalic, the axillary and the subclavian vein.

Studies comparing these options have been conducted in the past. Axillary venous access can be achieved either through axillary vein angiography or by ultrasound guidance. Nevertheless, appropriate training is required for the ultrasound-guided axillary puncture technique-as well as for the cephalic vein cutdown technique.

Data from randomized trials regarding direct comparison of the two methods in terms of efficacy and safety are very limited.

The purpose of the study is the comparison of the efficacy and safety of the ultrasound-guided axillary venous access technique versus the cephalic venous access using the cut-down technique in patients requiring intravenous cardiac device (single-chamber/dual-chamber pacemaker/defibrillator) implantation.

Conditions

  • Pacemaker
  • Implantable Cardioverter-defibrillator

Interventions

DEVICE

Ultrasound-guided axillary venous access

Venous access is obtained through ultrasound-guided axillary vein puncture and Seldinger technique.

DEVICE

Cephalic venous access

Venous access is obtained through cephalic vein cut-down.

Sponsors & Collaborators

  • University Hospital of Patras

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-09-30
Completion
2022-10-30

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04958369 on ClinicalTrials.gov