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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
Implantation of endovenous cardiac stimulation device.
Implantation of endovenous cardiac defibrillation device.
Fluoroscopy-guided axillary puncture to get vein access
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Implant Success
Success of the implant through the assigned access vein
Time frame: 30 days
Implant Complications
All implant related complications
Time frame: 30 days
Lead Complications
Lead fracture or dysfunction
Time frame: From date of implant until the date of first documented, assessed up to 48 months
Upper limb thrombosis
Thrombosis of the ipsilateral upper limb
Time frame: From date of implant until the date of first documented, assessed up to 48 months
Pneumothorax
Implant related pneumothorax
Time frame: 30 days
Bleeding
Implant related bleeding
Time frame: 30 days
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Optimized cephalic vein cutdown to get vein access