Clinical Trials Directory

Trials / Unknown

UnknownNCT03860090

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
Phase
N/A
Study type
Interventional
Enrollment
240 (actual)
Sponsor
Castilla-La Mancha Health Service · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEPacemaker implantImplantation of endovenous cardiac stimulation device.
DEVICEDefibrillator implantImplantation of endovenous cardiac defibrillation device.
PROCEDUREAXILLARY VEIN ACCESSFluoroscopy-guided axillary puncture to get vein access
PROCEDURECEPHALIC VEIN ACCESSOptimized cephalic vein cutdown to get vein access

Timeline

Start date
2017-10-01
Primary completion
2019-02-20
Completion
2022-10-01
First posted
2019-03-01
Last updated
2019-03-01

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03860090. Inclusion in this directory is not an endorsement.