Arrhythmias, CardiacZEROFLUOROAXINCT05101720
Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL
A study testing Ultrasound Guided Axillary Venous Access and Fluoroscopy-Guided Axillary Venous Access in people with Arrhythmias, Cardiac and Venous Puncture, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Arrhythmias, Cardiac, Venous Puncture, Implantable Defibrillator User
- What is being tested?
- Ultrasound Guided Axillary Venous Access and Fluoroscopy-Guided Axillary Venous Access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations
- Age > 18 years
Who cannot join
- Leadless pacemaker or subcutaneous ICD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation
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.
Read the 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
- Being tested
- Ultrasound Guided Axillary Venous Access, Fluoroscopy-Guided Axillary Venous Access
- Keywords
- pacemaker, ICD, arrhythmias, Cardiac Implantable Electronic Device, Vascular access, Venous puncture, Ultrasound, Fluoroscopy
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Axillary Venous AccessProcedure or surgery
Direct visualization of axillary vein will be obtained with ultrasound sterile linear probe.
Fluoroscopy-Guided Axillary Venous AccessProcedure or surgery
Fluoroscopic landmarks will be used and axillary venous puncture will be performed without ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Axillary Access | Experimental | Direct visualization of axillary vein with ultrasound will be obtained and used as a guidance for venous puncture. Receives: Procedure: Ultrasound Guided Axillary Venous Access |
| Fluoroscopic Guided Axillary Access | Active comparator | Standard technique: using the intersection of the lateral borders of the second and third rib as a radiological landmarks. Receives: Procedure: Fluoroscopy-Guided Axillary Venous Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.
Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.
Measured: One month after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Nov 2021
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Bertini, University Hospital of Ferrara
- Investigators
- Matteo Bertini, MD, PhD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101720
- Sponsor's protocol ID
- CE-AVEC 555/2021/Sper/AOUFe
- Acronym
- ZEROFLUOROAXI
- Status last verified
- Feb 2023
- First submitted
- 20 Oct 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38243998
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation
- ClinicalTrials.gov ID
- NCT05101720
- Acronym / sponsor ID
- ZEROFLUOROAXI / CE-AVEC 555/2021/Sper/AOUFe
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Axillary Access | Experimental | Procedure: Ultrasound Guided Axillary Venous AccessDirect visualization of axillary vein with ultrasound will be obtained and used as a guidance for venous puncture. |
| Fluoroscopic Guided Axillary Access | Active comparator | Procedure: Fluoroscopy-Guided Axillary Venous AccessStandard technique: using the intersection of the lateral borders of the second and third rib as a radiological landmarks. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations
- Age > 18 years
Key exclusion criteria (1 listed)
- Leadless pacemaker or subcutaneous ICD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Guided Axillary Venous AccessDirect visualization of axillary vein will be obtained with ultrasound sterile linear probe. | Procedure or surgery | Ultrasound Guided Axillary Access |
| Fluoroscopy-Guided Axillary Venous AccessFluoroscopic landmarks will be used and axillary venous puncture will be performed without ultrasound | Procedure or surgery | Fluoroscopic Guided Axillary Access |
Primary outcome
Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.
Time frame: One month after index procedure
Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 38243998Vitali 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Bertini, MD, PhD principal investigator
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Axillary Venous Access and Fluoroscopy-Guided Axillary Venous Access in people with Arrhythmias, Cardiac and Venous Puncture, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days. (time frame: One month after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05101720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.