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

Arrhythmias, Cardiac Clinical Trial

— ZEROFLUOROAXI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101720
• Other study ID #: CE-AVEC 555/2021/Sper/AOUFe
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations

• Age > 18 years

Exclusion Criteria:

• Leadless pacemaker or subcutaneous ICD

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria di Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.	Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.	One month after index procedure