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

Prospective Randomized Comparison of Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access. The CEPHAX Study.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03860090

Acronym

CEPHAX

Enrollment

240

Registered

2019-03-01

Start date

2017-10-01

Completion date

2022-10-31

Last updated

2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication, Defibrillators, Pacemaker Electrode Lead Fracture, Pacemakers

Keywords

Cephalic Vein, Axillary Vein

Brief summary

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.

Interventions

DEVICEPacemaker implant

Implantation of endovenous cardiac stimulation device.

DEVICEDefibrillator implant

Implantation of endovenous cardiac defibrillation device.

PROCEDUREAXILLARY VEIN ACCESS

Fluoroscopy-guided axillary puncture to get vein access

PROCEDURECEPHALIC VEIN ACCESS

Optimized cephalic vein cutdown to get vein access

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Implant Success	30 days	Success of the implant through the assigned access vein
Implant Complications	30 days	All implant related complications

Secondary

Measure	Time frame	Description
Bleeding	30 days	Implant related bleeding
Upper limb thrombosis	From date of implant until the date of first documented, assessed up to 48 months	Thrombosis of the ipsilateral upper limb
Pneumothorax	30 days	Implant related pneumothorax
Lead Complications	From date of implant until the date of first documented, assessed up to 48 months	Lead fracture or dysfunction

Other

Measure	Time frame	Description
Time of implant.	From the skin incision to the skin suture, assessed up to 180 minutes.	Intervention time.
Time to access.	From cutaneous incision to reach the right atrium with the guidewire, assessed up to 45 minutes.	Time until reaching venous access.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026