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

NCT03860090 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-03-01

No results posted yet for this study

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.

Conditions

  • Pacemakers
  • Defibrillators
  • Complication
  • Pacemaker Electrode Lead Fracture

Interventions

DEVICE

Pacemaker implant

Implantation of endovenous cardiac stimulation device.

DEVICE

Defibrillator implant

Implantation of endovenous cardiac defibrillation device.

PROCEDURE

AXILLARY VEIN ACCESS

Fluoroscopy-guided axillary puncture to get vein access

PROCEDURE

CEPHALIC VEIN ACCESS

Optimized cephalic vein cutdown to get vein access

Sponsors & Collaborators

  • Castilla-La Mancha Health Service

    lead OTHER

Principal Investigators

  • Javier Jiménez Díaz, Dr. · Arrhythmia Unit Director

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-02-20
Completion
2022-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03860090 on ClinicalTrials.gov