Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2019-A02952-55 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-guided axillary vein access | Active Comparator | This group of patients will receive the cardiac implantable electronic device with ultrasound-guided axillary venous access. |
|
| Cephalic vein access | Active Comparator | This group of patients will receive the cardiac implantable electronic device with cephalic venous access. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided axillary vein access | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Success of venous access | 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. | Intervention time (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to venous access | Time from cutaneous incision to reach the right atrium with all needed guidewire using the assigned venous access technique | Intervention time (day 0) |
| Procedure duration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hopital de la Croix Rousse | Lyon | 69004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37832512 | Result | Charles P, Ditac G, Montoy M, Thenard T, Courand PY, Lantelme P, Harbaoui B, Fareh S. Intra-pocket ultrasound-guided axillary vein puncture vs. cephalic vein cutdown for cardiac electronic device implantation: the ACCESS trial. Eur Heart J. 2023 Dec 7;44(46):4847-4858. doi: 10.1093/eurheartj/ehad629. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cephalic vein access | Device | 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. |
|
Time from cutaneous incision to skin suture
| Intervention time (day 0) |
| Fluoroscopy time | Duration of fluoroscopy use during intervention | Intervention time (day 0) |
| X-Ray exposure | X-ray exposure during intervention, measured in mGycm2 | Intervention time (day 0) |
| Complication | 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. | Intervention time (day 0) |
| Cardiac implantable electronic device (CIED) related infection | 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. | Month 3 |