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

NCT05101720 | Completed DMC

• 1 other identifier: CE-AVEC 555/2021/Sper/AOUFe
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

pacemaker; ICD; arrhythmias; Cardiac Implantable Electronic Device; Vascular access; Venous puncture; Ultrasound; Fluoroscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ultrasound Guided Axillary Access

EXPERIMENTAL

Direct visualization of axillary vein with ultrasound will be obtained and used as a guidance for venous puncture.

Procedure: Ultrasound Guided Axillary Venous Access

Fluoroscopic Guided Axillary Access

ACTIVE COMPARATOR

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

Interventions

Ultrasound Guided Axillary Venous Access PROCEDURE

Direct visualization of axillary vein will be obtained with ultrasound sterile linear probe.

Ultrasound Guided Axillary Access

Fluoroscopy-Guided Axillary Venous Access PROCEDURE

Fluoroscopic landmarks will be used and axillary venous puncture will be performed without ultrasound

Fluoroscopic Guided Axillary Access

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Leadless pacemaker or subcutaneous ICD

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, 44124, Italy

Location

Related Publications (1)

• Vitali F, Malagu M, Bianchi N, De Raffele M, Manfrini M, Gibiino F, Boccadoro A, Azzolini G, Balla C, Bertini M. Ultrasound-Guided Venous Axillary Access Versus Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI Randomized Trial. JACC Clin Electrophysiol. 2024 Mar;10(3):554-565. doi: 10.1016/j.jacep.2023.11.020. Epub 2024 Jan 17.

  PMID: 38243998 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matteo Bertini, MD, PhD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 1, 2021
• Study Start: November 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

IT (1)