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

Sponsor

University Hospital of Ferrara (Other)

Overall Status

Recruiting

CT.gov ID

NCT05101720

Collaborator

(none)

280

Enrollment

Location

Arms

Anticipated Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmias, Cardiac Venous Puncture Implantable Defibrillator User Pacemaker Complication Vascular Access Complication Fluoroscopy; Adverse Effect	Procedure: Ultrasound Guided Axillary Venous Access Procedure: Fluoroscopy-Guided Axillary Venous Access	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.