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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-17

Study Completion Date

2022-11-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Pacemaker Implantable Cardioverter-defibrillator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound-guided axillary vein access

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

Group Type ACTIVE_COMPARATOR

Ultrasound-guided axillary vein access

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Cephalic vein access

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No