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

Not Applicable

Completed

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

• Registration Number: NCT05101720
• Lead Sponsor: University Hospital of Ferrara

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.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study Start: 2021-11-01
• Study First Posted: 2021-11-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-05
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

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

Exclusion Criteria

• Leadless pacemaker or subcutaneous ICD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Axillary Access	Ultrasound Guided Axillary Venous Access	Direct visualization of axillary vein with ultrasound will be obtained and used as a guidance for venous puncture.
Fluoroscopic Guided Axillary Access	Fluoroscopy-Guided Axillary Venous Access	Standard technique: using the intersection of the lateral borders of the second and third rib as a radiological landmarks.

Primary Outcome Measures

Name	Time	Method
Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.	One month after index procedure	Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria di Ferrara; 🇮🇹 Ferrara, Italy