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

Pacemaker Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649788
• Other study ID #: 69HCL19_0540
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: November 25, 2022

Study information

• Verified date: February 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 25, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Implantable Cardioverter-defibrillator
• Pacemaker

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hopital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Procedure duration	Time from cutaneous incision to skin suture	Intervention time (day 0)
Secondary	Fluoroscopy time	Duration of fluoroscopy use during intervention	Intervention time (day 0)
Secondary	X-Ray exposure	X-ray exposure during intervention, measured in mGycm2	Intervention time (day 0)
Secondary	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)
Secondary	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