Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access (CEPHAX)

Castilla-La Mancha Health Service

Status: Unknown

Conditions: Pacemaker Electrode Lead Fracture; Pacemakers; Complication; Defibrillators

Treatments: Device: Pacemaker implant; Procedure: CEPHALIC VEIN ACCESS; Procedure: AXILLARY VEIN ACCESS; Device: Defibrillator implant

Study type: Interventional

Funder types: Other

Identifiers

NCT03860090

A-276

Details and patient eligibility

About

This clinical trial evaluates the efficacy and safety of axillary versus cephalic venous access in the pacemakers and defibrillators implantation.

Half of participants will receive the implant via fluoroscopy guided axillary venous access and the other half will receive the implant via improved cephalic venous access.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a endovenous pacemaker or defibrillator indication.

Exclusion criteria

• Pre-existing ipsilateral pacing electrode.
• Previous ipsilateral lymphadenectomy.
• Indication of cardiac resynchronization therapy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

AXILLARY VEIN ACCESS

Active Comparator group

Description:

This group of subjects will receive the implant of device via fluoroscopy-guided axillary puncture technique.

Treatment:

Device: Pacemaker implant

Device: Defibrillator implant

Procedure: AXILLARY VEIN ACCESS

CEPHALIC VEIN ACCESS

Active Comparator group

Description:

This group of subjects will receive the implant of device via optimized cephalic vein cutdown technique.

Treatment:

Device: Pacemaker implant

Device: Defibrillator implant

Procedure: CEPHALIC VEIN ACCESS