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

NCT04958369 | Completed

• 1 other identifier: 93/01.03.2021
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pacemaker; implantable cardioverter-defibrillator; axillary vein; cephalic vein; ulatraound

Outcome Measures

Primary Outcomes (1)

• Rate of successful cardiac device implantation

  Intervention time (Day 0)

Secondary Outcomes (7)

• Duration of lead insertion procedure

  Intervention time (Day 0)

• Total procedure duration

  Intervention time (Day 0)

• Radiation dose

  Intervention time (Day 0)

• Fluoroscopy time

  Intervention time (Day 0)

• Procedure-related complication rate (pneumothorax, cardiac tamponade, pocket hematoma, lead displacement, fever, need for antibiotic treatment)

  Day 0-30

Study Arms (2)

Ultrasound-guided axillary venous access

ACTIVE COMPARATOR

Cardiac device implantation will be performed with ultrasound-guided axillary venous access.

Device: Ultrasound-guided axillary venous access

Cephalic venous access

ACTIVE COMPARATOR

Cardiac device implantation will be performed with conventional cephalic venous access (cut-down technique).

Device: Cephalic venous access

Interventions

Ultrasound-guided axillary venous access DEVICE

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

Ultrasound-guided axillary venous access

Cephalic venous access DEVICE

Venous access is obtained through cephalic vein cut-down.

Cephalic venous access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Indication for single- or dual-chamber pacemaker of defibrillator implantation
• Written informed consent

You may not qualify if:

• Indication for biventricular pacemaker/defibrillator
• Upgrade in pacing or defibrillation system

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Rion, 26504, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 12, 2021
• Study Start: May 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)