Clinical trial NCT05101720: Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL
Official title: Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.
timeFrame: One month after index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
Study officials:
affiliation: Università degli Studi di Ferrara
name: Matteo Bertini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: