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

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

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac; Implantable Defibrillator User; Vascular Access Complication; Venous Puncture; Pacemaker Complication; Fluoroscopy; Adverse Effect
• Intervention / Treatment: Procedure: Ultrasound Guided Axillary Venous Access; Procedure: Fluoroscopy-Guided Axillary Venous Access

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matteo Bertini, MD, PhD; Phone Number: +39 532 236269; Email: matteo.bertini@unife.it

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Azienda Ospedaliero-Universitaria di Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations
• Age > 18 years

Exclusion Criteria:

• Leadless pacemaker or subcutaneous ICD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ultrasound Guided Axillary Access; Direct visualization of axillary vein with ultrasound will be obtained and used as a guidance for venous puncture.	Procedure: Ultrasound Guided Axillary Venous Access; Direct visualization of axillary vein will be obtained with ultrasound sterile linear probe.
ACTIVE_COMPARATOR: Fluoroscopic Guided Axillary Access; Standard technique: using the intersection of the lateral borders of the second and third rib as a radiological landmarks.	Procedure: Fluoroscopy-Guided Axillary Venous Access; Fluoroscopic landmarks will be used and axillary venous puncture will be performed without ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ACTUAL): November 30, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (ACTUAL): November 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; ICD; Cardiac Implantable Electronic Device; pacemaker; Vascular access; Fluoroscopy; arrhythmias; Venous puncture
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CE-AVEC 555/2021/Sper/AOUFe

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No