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

NCT ID: NCT05101720

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ultrasound Guided Axillary Access

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

Group Type: EXPERIMENTAL

Ultrasound Guided Axillary Venous Access

Intervention Type: PROCEDURE

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

Fluoroscopic Guided Axillary Access

Standard technique: using the intersection of the lateral borders of the second and third rib as a radiological landmarks.

Group Type: ACTIVE_COMPARATOR

Fluoroscopy-Guided Axillary Venous Access

Intervention Type: PROCEDURE

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

Interventions

Ultrasound Guided Axillary Venous Access

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

Intervention Type: PROCEDURE

Fluoroscopy-Guided Axillary Venous Access

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Leadless pacemaker or subcutaneous ICD

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Matteo Bertini

MD, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matteo Bertini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Locations

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 38243998 (View on PubMed)

Other Identifiers

CE-AVEC 555/2021/Sper/AOUFe

Identifier Type: -

Identifier Source: org_study_id