Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices.

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04649788
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker; Implantable Cardioverter-defibrillator	Device: Ultrasound-guided axillary vein access; Device: Cephalic vein access	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Comparison of Efficacy and Safety of Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices
• Actual Study Start Date: Jul 17, 2020
• Anticipated Primary Completion Date: Jul 17, 2022
• Anticipated Study Completion Date: Oct 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ultrasound-guided axillary vein access This group of patients will receive the cardiac implantable electronic device with ultrasound-guided axillary venous access.	Device: Ultrasound-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.
Active Comparator: Cephalic vein access This group of patients will receive the cardiac implantable electronic device with cephalic venous access.	Device: Cephalic 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. Procedure duration [Intervention time (day 0)]

   Time from cutaneous incision to skin suture

3. Fluoroscopy time [Intervention time (day 0)]

   Duration of fluoroscopy use during intervention

4. X-Ray exposure [Intervention time (day 0)]

   X-ray exposure during intervention, measured in mGycm2

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon - Hopital de la Croix Rousse	Lyon		France	69004

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04649788
• Other Study ID Numbers: 69HCL19_0540; ANSM
• First Posted: Dec 2, 2020
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: pacemaker; implantable cardioverter-defibrillator; axillary vein; cephalic vein; ultrasound

Study Results

No Results Posted as of Nov 24, 2021