Prospective Randomized Comparison of Efficacy and Safety of Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 18 years or older

• Indication for endovenous pacemaker or cardioverter-defibrillator (single or double room)

Locations
Other Locations
France
Hospices Civils de Lyon - Hopital de la Croix Rousse
Recruiting
Lyon
Contact Information
Primary
Paul Charles
paul.charles@chu-lyon.fr
+33472071672
Backup
Mathieu MONTOY
Mathieu.montoy@chu-lyon.fr
+33472072537
Time Frame
Start Date: July 17, 2020
Estimated Completion Date: October 17, 2022
Participants
Target number of participants: 200
Treatments
Active Comparator: Ultrasound-guided axillary vein access
This group of patients will receive the cardiac implantable electronic device with ultrasound-guided axillary venous access.
Active Comparator: Cephalic vein access
This group of patients will receive the cardiac implantable electronic device with cephalic venous access.
Authors
Paul CHARLES
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov

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