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

NCT05101720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2023-02-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Principal Investigators

  • Matteo Bertini, MD, PhD · Università degli Studi di Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-11-30
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05101720 on ClinicalTrials.gov