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

Civil Hospices of Lyon

Status: Completed

Conditions: Implantable Cardioverter-defibrillator; Pacemaker

Treatments: Device: Cephalic vein access; Device: Ultrasound-guided axillary vein access

Study type: Interventional

Funder types: Other

Identifiers

NCT04649788

69HCL19_0540

ANSM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Ultrasound-guided axillary vein access

Active Comparator group

Description:

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

Treatment:

Device: Ultrasound-guided axillary vein access

Cephalic vein access

Active Comparator group

Description:

This group of patients will receive the cardiac implantable electronic device with cephalic venous access.

Treatment:

Device: Cephalic vein access