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Trial registered on ANZCTR


Registration number
ACTRN12623000982617
Ethics application status
Approved
Date submitted
23/06/2023
Date registered
8/09/2023
Date last updated
8/09/2023
Date data sharing statement initially provided
8/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of conventional versus high-frequency jet ventilation (HFJV) on catheter stability and duration of pulmonary vein electrical isolation procedures for atrial fibrillation
Scientific title
Impact of high-frequency jet ventilation (HFJV) on ablation catheter stability and duration of pulmonary vein electrical isolation procedures for atrial fibrillation in adults
Secondary ID [1] 309521 0
None
Universal Trial Number (UTN)
Trial acronym
JET AF-Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 329805 0
Condition category
Condition code
Cardiovascular 326705 326705 0 0
Other cardiovascular diseases
Anaesthesiology 326706 326706 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- The intervention consists of the use of high frequency jet ventilation as a primary mode of ventilation after transseptal puncture, when performing a percutaneous pulmonary vein ablation procedure in the context of atrial fibrillation. Its settings will be as follows (Starting working pressure 0.02 bar/kg, Rate 150/minute, FiO2 50%, I/T 30%).
After induction of general anaesthesia, intubation will be followed by insertion of a LaserJet catheter (Acutronic Medical Systems, Hirzel, Schweiz) into the endotracheal tube to perform jet ventilation.
Arterial blood gas and EtCO2 measurement via 5 manual ventilations will be performed immediately after transseptal atrial puncture and before removal of the left atrial ablation catheter.
The duration of the procedure is defined by the time between transseptal puncture of the left atrium and removal of the ablation catheter from the left atrium, once all four pulmonary veins have been radiofrequently isolated. No maximum time limit was defined for the procedure. The mean estimate of procedural time used for statistical power and sample calculation was 120 minutes per procedure.
Patients in this arm of the study will also receive a 5 ml 0.9% NaCl aerosol in the recovery room after the procedure.
- A printed and electronic protocol for the management of ventilation according to the patient's assigned arm will be immediately available in the cardiac catheterisation room.
- The procedure will be performed by a specialist anaesthesiologist trained in the use of high frequency jet ventilation.
- The procedure will be performed during an inpatient stay for a pulmonary vein ablation procedure in the context of atrial fibrillation.
- One procedure per patient
- CHU UCL Namur, Godinne site, a tertiary university teaching hospital. The cardiological intervention will take place in a cardiac catheterisation room dedicated to the performance of interventional rhythmology procedures.

Adaptation of the procedure:
- The working pressure of the jet ventilation will be adapted to the EtCO2, by measuring the EtCO2 during the gas measurements described above and every 30 minutes after the start of the jet ventilation.
Intervention code [1] 325953 0
Treatment: Devices
Comparator / control treatment
Participants in the control group will receive usual anesthesia care and conventional mechanical ventilation (Pressure controlled ventilation with Tidal volume 6-8 ml/kg, Frequence 10-16/minute, PEEP 5 cmH2O, I/E 1:2, FiO2 50%)
Control group
Active

Outcomes
Primary outcome [1] 334583 0
Change in total ablation time recorded at the patient's bedside using a sheet completed by the cardiologist and anaesthetist according to the anaesthesia record.
Timepoint [1] 334583 0
Immediately at the end of the procedure (before the anaesthesia record is closed and the patient is transferred to the recovery room)
Primary outcome [2] 334584 0
Modification of the time required for complete isolation of the four pulmonary veins by the ablation probe, recorded at the patient's bedside at the end of the procedure, using a sheet completed by the cardiologist and anaesthetist in accordance with the anaesthesia record and the data from the electrophysiological ablation programme.
Timepoint [2] 334584 0
Immediately at the end of the procedure (before the anaesthesia record is closed and the patient is transferred to the recovery room)
Primary outcome [3] 334586 0
Clinical efficacy defined as :
- Acute success of pulmonary vein isolation, recorded at the patient's bedside at the end of the procedure, using a sheet completed by the cardiologist and anaesthetist in accordance with the anaesthesia record and the data from the electrophysiological ablation programme.
Timepoint [3] 334586 0
- Acute success of pulmonary vein isolation : Immediately at the end of the procedure (before the anaesthesia record is closed and the patient is transferred to the recovery room)
Secondary outcome [1] 421297 0
Presence or absence of arterial hypercapnia related to high-frequency jet ventilation as measured by arterial blood gases at the start of the procedure (after transseptal puncture) and at the end of the procedure (before removal of the catheters from the left atrium).
Timepoint [1] 421297 0
from the beginning to the end of pulmonary veins isolation
Secondary outcome [2] 421298 0
Presence or absence of elevation of arterial lactate levels related to high-frequency jet ventilation as measured by arterial blood gases at the start of the procedure (after transseptal puncture) and at the end of the procedure (before removal of the catheters from the left atrium).
Timepoint [2] 421298 0
from the beginning to the end of pulmonary veins isolation
Secondary outcome [3] 421299 0
The presence or absence of peripheral hypoxaemia (< 94%) between the beginning and end of the period of high-frequency jet ventilation, based on data from the anaesthetic record, assessed at the end of the procedure.
Timepoint [3] 421299 0
from the beginning to the end of pulmonary veins isolation
Secondary outcome [4] 421300 0
Hemodynamic stability of high-frequency jet ventilation (mean arterial pressure and systolic arterial pressure) between the beginning and end of the high-frequency jet ventilation period, based on data from the anaesthesia record, assessed at the end of the procedure.
Timepoint [4] 421300 0
from the beginning to the end of pulmonary veins isolation
Secondary outcome [5] 426243 0
Presence of atrial fibrillation at follow-up determined by bedside electrocardiogram. This is a primary outcome as well.
Timepoint [5] 426243 0
3-months follow up and 1-year follow up

Eligibility
Key inclusion criteria
Age > 18 years
Documentation of atrial fibrillation for which an indication for ablation has been made by a cardiologist and accepted by the patient
Written agreement to the research protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Extreme COPD (GOLD 4)
- Lung transplant patients
- Patients with cystic fibrosis, primary ciliary dyskinesia or other conditions involving mucociliary escalator fragility
- Corrected complex congenital heart disease
- Morbid obesity (BMI >40)
- Patient allergic to soy ( contraindicating the use of propofol necessary for induction and maintenance of anaesthesia in high frequency jet-ventilation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation is not concealed because the two ventilation modes make very different noises. The person (cardiologist) who decided whether a person was eligible for the trial knew which group the person would be in. He could then tell the anaesthetist which group the patient was in to determine the type of ventilation required.
Allocation is therefore not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Redcap)


Factor(s) used for the stratification :
- Operator (OX or BR)
- AF caractéristics (paroxystic ou persistant)
- Left Atrium size determined by CT-Scan (< 75 ml, 75-100ml or >100ml).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We assumed a 15-minute procedure reduction with jet ventilation, which means that we would need 150 patients (2x75) to have a 63 % chance of demonstrating significance. If the benefit is > 15 min, fewer patients will be needed

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
32
Final
Recruitment outside Australia
Country [1] 25417 0
Belgium
State/province [1] 25417 0
Namur

Funding & Sponsors
Funding source category [1] 313715 0
Self funded/Unfunded
Name [1] 313715 0
Adrien Maseri
Country [1] 313715 0
Belgium
Funding source category [2] 313727 0
Hospital
Name [2] 313727 0
CHU UCL Namur
Country [2] 313727 0
Belgium
Primary sponsor type
Individual
Name
Adrien Maseri
Address
Dr. Adrien MaseriCHU UCL Namur, Site GodinneService d'Anesthésiologieavenue Dr. G. Thérasse, n°15530 Yvoir
Country
Belgium
Secondary sponsor category [1] 315528 0
Individual
Name [1] 315528 0
Benoît Robaye
Address [1] 315528 0
Dr. Benoit RobayeCHU UCL Namur, Site GodinneService de Cardiologieavenue Dr. G. Thérasse, n°15530 Yvoir
Country [1] 315528 0
Belgium
Other collaborator category [1] 282658 0
Individual
Name [1] 282658 0
Quentin Delhez
Address [1] 282658 0
Dr. Quentin DelhezCHU UCL Namur, Site GodinneService d'Anesthésiologieavenue Dr. G. Thérasse, n°15530 Yvoir
Country [1] 282658 0
Belgium
Other collaborator category [2] 282664 0
Individual
Name [2] 282664 0
Olivier Xhaët
Address [2] 282664 0
Dr. Olivier XhaëtCHU UCL Namur, Site GodinneService de Cardiologieavenue Dr. G. Thérasse, n°15530 Yvoir
Country [2] 282664 0
Belgium
Other collaborator category [3] 282665 0
Individual
Name [3] 282665 0
Michaël Hardy
Address [3] 282665 0
Dr. Michaël HardyCHU UCL Namur, Site GodinneService d'Anesthésiologieavenue Dr. G. Thérasse, n°15530 Yvoir
Country [3] 282665 0
Belgium
Other collaborator category [4] 282666 0
Individual
Name [4] 282666 0
Maximillien Gourdin
Address [4] 282666 0
Pr. Maximillien GourdinCHU UCL Namur, Site GodinneService d'Anesthésiologieavenue Dr. G. Thérasse, n°15530 Yvoir
Country [4] 282666 0
Belgium
Other collaborator category [5] 282667 0
Individual
Name [5] 282667 0
Fabien Dormal
Address [5] 282667 0
Mr. Fabien DormalCHU UCL Namur, Site GodinneService de Cardiologieavenue Dr. G. Thérasse, n°15530 Yvoir
Country [5] 282667 0
Belgium

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312887 0
Commission d’éthique médicale CHU UCL Namur – site Godinne
Ethics committee address [1] 312887 0
Commission d’éthique médicale CHU UCL Namur – site GodinneRue Dr Gaston Thérasse 15530 Yvoir
Ethics committee country [1] 312887 0
Belgium
Date submitted for ethics approval [1] 312887 0
Approval date [1] 312887 0
27/12/2022
Ethics approval number [1] 312887 0
B0392022000094

Summary
Brief summary
Atrial fibrillation (AF) is the most frequently observed sustained arrhythmia in cardiology. Treatment of AF is increasingly based on a procedure called AF ablation, which involves electrical isolation of the pulmonary veins. Currently, AF ablation takes about 2-3 hours.

The technique involves the introduction of an ablation catheter into the patient's left atrium, under general anaesthesia and endotracheal intubation, which will allow linear lesions to be made by applying a radiofrequency (RF) current. In the patient's atrium, the catheter is visualised on a screen by a programme allowing a 3-dimensional reconstruction of the cardiac cavities and the visualisation of the catheter in real time. To ensure the creation of sufficiently deep ablation lesions, the stability of the catheter during firing is important. The less the catheter moves during the RF shot, the more the energy delivered will be concentrated on a small area and the lesion will be considered effective.
Patients are anaesthetised during the procedure and must be ventilated by a ventilator. Part of the catheter movement therefore comes from the ventilatory cycles.

Hypothesis
By using a "high frequency jet ventilation" mode, the chest movements related to air insufflations by the ventilator are almost abolished. This should improve catheter stability, allowing fewer radiofrequency shots to be taken and less time to stabilise the catheter. This should reduce the duration of the procedures, which may allow more procedures to be performed. This may also be an advantage for the patient (shorter general anaesthesia and therefore less risk of complications, less risk of thrombus formation on the catheters as they will remain in the heart chambers for less time). The quality of the ablation lesions should be improved by the stability of the catheter, which may result in easier and longer lasting vein isolation.

The rare complications associated with JET ventilation are related to the possibility of generating overpressure in the airways (risk of pulmonary barotrauma) and the impossibility of checking the outflow of CO2 at the tube, with possible hypercapnia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126226 0
Dr Benoît Robaye
Address 126226 0
Service de Cardiologierue Dr. G. Thérasse 15530 Yvoir
Country 126226 0
Belgium
Phone 126226 0
+3281423626
Fax 126226 0
Email 126226 0
benoit.robaye@chuuclnamur.uclouvain.be
Contact person for public queries
Name 126227 0
Dr Benoît Robaye
Address 126227 0
Service de Cardiologierue Dr. G. Thérasse 15530 Yvoir
Country 126227 0
Belgium
Phone 126227 0
+3281423626
Fax 126227 0
Email 126227 0
benoit.robaye@chuuclnamur.uclouvain.be
Contact person for scientific queries
Name 126228 0
Dr Benoît Robaye
Address 126228 0
Service de Cardiologierue Dr. G. Thérasse 15530 Yvoir
Country 126228 0
Belgium
Phone 126228 0
+3281423626
Fax 126228 0
Email 126228 0
benoit.robaye@chuuclnamur.uclouvain.be

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 6 months and ending 5 years following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (benoit.robaye@chuuclnamur.uclouvain.be)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19001Study protocol  benoit.robaye@chuuclnamur.uclouvain.be 385792-(Uploaded-04-05-2023-21-26-48)-Study-related document.pdf
19002Informed consent form  benoit.robaye@chuuclnamur.uclouvain.be 385792-(Uploaded-04-05-2023-21-25-34)-Study-related document.pdf
19003Ethical approval  benoit.robaye@chuuclnamur.uclouvain.be 385792-(Uploaded-04-05-2023-21-23-33)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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