Implantable Cardioverter-defibrillator, Pacemaker
Conditions
Keywords
pacemaker, implantable cardioverter-defibrillator, axillary vein, cephalic vein, ultrasound
Brief summary
Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe. Ultrasound-guided axillary vein access is a promising alternative but there is a lack of clinical evidence supporting this technique. The purpose of this study is to compare the efficacy and safety of ultrasound-guided axillary vein access versus cephalic venous cutdown for implantation of endovenous CIED. Half of patients is implanted using an ultrasound-guided axillary vein puncture. The other half is implanted using a cephalic vein cutdown. After venous access is achieved, implantation procedure is identical in the two arms.
Interventions
DEVICEUltrasound-guided axillary vein access
Venous access is performed through ultrasound-guided axillary vein puncture and Seldinger technique. After venous access is obtained, a guide-wire is advanced through the access needle, and the tip of the guide-wire is positioned in the right cardiac atrium.
DEVICECephalic vein access
Venous access is performed through a cephalic vein cutdown approach. After venous access is obtained, a guide-wire is advanced and the tip of the guide-wire is positioned in the right cardiac atrium.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Indication for endovenous pacemaker or cardioverter-defibrillator (single or double room)
Exclusion criteria
* History of previously implanted endocardial lead * Indication for cardiac resynchronization therapy * Impossibility of venous access * Unable/unwilling to provide informed consent * Pregnant or breastfeeding woman * Participating in another clinical study which can interfere with this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of venous access | Intervention time (day 0) | This outcome is measured by the operator during the intervention. It is the ability to successfully cannulate the vein and have all needed guidewire in the right atrium using the assigned venous access technique. The outcome is a binary value: success or failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure duration | Intervention time (day 0) | Time from cutaneous incision to skin suture |
| Fluoroscopy time | Intervention time (day 0) | Duration of fluoroscopy use during intervention |
| Time to venous access | Intervention time (day 0) | Time from cutaneous incision to reach the right atrium with all needed guidewire using the assigned venous access technique |
| Complication | Intervention time (day 0) | All implant related complications including brachial plexus palsy, major pocket hematoma (hematoma requiring evacuation or transfusion or prolonged hospitalization), pneumothorax, hemothorax, pericardial effusion, lead dislodgement, device infection, venous thrombosis. |
| Cardiac implantable electronic device (CIED) related infection | Month 3 | Local and systemic signs of CIED related infection will be monitored during follow-up. The definition and classification of CIED related infection are based on the current guideline and expert consensus statement. |
| X-Ray exposure | Intervention time (day 0) | X-ray exposure during intervention, measured in mGycm2 |
Countries
France
Outcome results
None listed