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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Comparison of Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access. The CEPHAX Study.

Conditions
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Pacemakers, Defibrillators, Complication, Pacemaker Electrode Lead Fracture

Intervention / Treatment
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* Device: Pacemaker implant
* Device: Defibrillator implant
* Procedure: AXILLARY VEIN ACCESS
* Procedure: CEPHALIC VEIN ACCESS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AXILLARY VEIN ACCESS<br>This group of subjects will receive the implant of device via fluoroscopy-guided axillary puncture technique. | Device: Pacemaker implant<br>* Implantation of endovenous cardiac stimulation device.<br>Device: Defibrillator implant<br>* Implantation of endovenous cardiac defibrillation device.<br>Procedure: AXILLARY VEIN ACCESS<br>* Fluoroscopy-guided axillary puncture to get vein access<br>|
| Active Comparator: CEPHALIC VEIN ACCESS<br>This group of subjects will receive the implant of device via optimized cephalic vein cutdown technique. | Device: Pacemaker implant<br>* Implantation of endovenous cardiac stimulation device.<br>Device: Defibrillator implant<br>* Implantation of endovenous cardiac defibrillation device.<br>Procedure: CEPHALIC VEIN ACCESS<br>* Optimized cephalic vein cutdown to get vein access<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Success | Success of the implant through the assigned access vein | 30 days | 
| Implant Complications | All implant related complications | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead Complications | Lead fracture or dysfunction | From date of implant until the date of first documented, assessed up to 48 months | 
| Upper limb thrombosis | Thrombosis of the ipsilateral upper limb | From date of implant until the date of first documented, assessed up to 48 months | 
| Pneumothorax | Implant related pneumothorax | 30 days | 
| Bleeding | Implant related bleeding | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cephalic Vein, Axillary Vein