NCT05101720

Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL

Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable cardioverter-defibrillator implantations.

Detailed description

Rationale: axillary, cephalic and subclavian venous accesses are commonly used in pacemaker and implantable cardioverter defibrillator implantations. Axillary puncture and cephalic vein surgical cutdown are both recommended in international guidelines due to low risk of pneumothorax and chronic lead complications. Sometimes cephalic vein is not available. Today axillary puncture is performed under fluoroscopic view and some complications still exist with this venous access as pneumothorax and arterial puncture. Axillary vein direct visualization can be obtained with standard venography or with ultrasound. With direct visualization and puncture of the axillary vein under ultrasound guidance venography with radiocontrast could be avoided. Less radiation exposure for patient and operator and direct visualization of the needle are possible with lower periprocedural complications using ultrasound. Despite the great interest for ultrasound guided axillary puncture up today we have few data on its feasibility. Our hypothesis is that ultrasound guided axillary access is more safe and more feasible than the standard fluoroscopic technique. We decided to enroll all the patients undergoing standard transvenous pacemaker or cardioverter implantable defibrillator. We randomize the patients with 1:1 fashion to axillary venous access under fluoroscopic guidance or to ultrasound guided axillary venous access. Obiectives: to asses safety, feasibility of the ultrasound guided venous puncture. Main Endpoint: composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.

Conditions

• Arrhythmias, Cardiac
• Venous Puncture
• Implantable Defibrillator User
• Pacemaker Complication
• Vascular Access Complication
• Fluoroscopy; Adverse Effect

Interventions

Type	Name	Description
PROCEDURE	Ultrasound Guided Axillary Venous Access	Direct visualization of axillary vein will be obtained with ultrasound sterile linear probe.
PROCEDURE	Fluoroscopy-Guided Axillary Venous Access	Fluoroscopic landmarks will be used and axillary venous puncture will be performed without ultrasound

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-11-30
• Completion: 2022-12-31
• First posted: 2021-11-01
• Last updated: 2023-02-08

Locations

1 site across 1 country: Italy