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

Not Applicable
Conditions
Pacemaker Electrode Lead Fracture
Defibrillators
Complication
Pacemakers
Registration Number
NCT03860090
Lead Sponsor
Castilla-La Mancha Health Service
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
240
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Implant Success30 days

Success of the implant through the assigned access vein

Implant Complications30 days

All implant related complications

Secondary Outcome Measures
NameTimeMethod
Lead ComplicationsFrom date of implant until the date of first documented, assessed up to 48 months

Lead fracture or dysfunction

Pneumothorax30 days

Implant related pneumothorax

Bleeding30 days

Implant related bleeding

Upper limb thrombosisFrom date of implant until the date of first documented, assessed up to 48 months

Thrombosis of the ipsilateral upper limb

Trial Locations

Locations (1)

Hospital General Universitario de Ciudad Real

🇪🇸

Ciudad Real, Spain

Hospital General Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain

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