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

Not Applicable

Completed

• Conditions: Implantable Cardioverter-defibrillator; Pacemaker
• Interventions: Device: Ultrasound-guided axillary vein access; Device: Cephalic vein access

• Registration Number: NCT04649788
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-17
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-02
• Primary Completion: 2022-07-15
• Study Completion: 2022-11-25
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided axillary vein access	Ultrasound-guided axillary vein access	This group of patients will receive the cardiac implantable electronic device with ultrasound-guided axillary venous access.
Cephalic vein access	Cephalic vein access	This group of patients will receive the cardiac implantable electronic device with cephalic venous access.

Primary Outcome Measures

Name	Time	Method
Success of venous access	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 Outcome Measures

Name	Time	Method
X-Ray exposure	Intervention time (day 0)	X-ray exposure during intervention, measured in mGycm2
Cardiac implantable electronic device (CIED) related infection	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.
Procedure duration	Intervention time (day 0)	Time from cutaneous incision to skin suture
Fluoroscopy time	Intervention time (day 0)	Duration of fluoroscopy use during intervention
Time to venous access	Intervention time (day 0)	Time from cutaneous incision to reach the right atrium with all needed guidewire using the assigned venous access technique
Complication	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.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse; 🇫🇷 Lyon, France