Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access (CEPHAX)
Not Applicable
- Conditions
- Pacemaker Electrode Lead FractureDefibrillatorsComplicationPacemakers
- 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
Name Time Method Implant Success 30 days Success of the implant through the assigned access vein
Implant Complications 30 days All implant related complications
- Secondary Outcome Measures
Name Time Method Lead Complications From date of implant until the date of first documented, assessed up to 48 months Lead fracture or dysfunction
Pneumothorax 30 days Implant related pneumothorax
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
Trial Locations
- Locations (1)
Hospital General Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital General Universitario de Ciudad Real🇪🇸Ciudad Real, Spain