Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes
About this trial
Interventional radiology has become a widespread technique used in various fields of medicine to diagnose or treat numerous pathologies. However, the risk of X-rays must be taken into account. In 2019, the French Authority on Nuclear Safety published diagnostic reference levels for radio-guided interventional practices for 10 interventional radiology procedures and 2 interventional cardiology procedures, based on studies published by the French Society of Medical Physics in collaboration with the French Society of Radiology and the French Coronary Artery Disease and Interventional Cardiology Group. Reference levels for interventional procedures under CT guidance were also defined in 2020 following a national multicenter study coordinated by Nîmes University Hospital (NIMAO NRD-SI). However, no national multicentre studies have ever defined reference levels for radioguided interventional procedures in rhythmology. The aim of this study is to define standard national dosimetric levels for a number of radioguided interventional procedures in rhythmology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult male/female patient (≥ 18 years)
Body Mass Index (BMI) between 18 and 35 kg/m².
Disqualifiers
Patient whose procedure does not require X-rays
Pregnant women
Trial population
Study population: All patients benefitting from a rhythmology procedure to be performed among the procedures defined in the inclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Radio-guided interventions to correct heart rhythm disorders
RadiationAll patients in the cohort will be undergoing one of the following radio-guided procedures : * Insertion of a single-chamber pacemaker with lead * Insertion of a dual-chamber pacemaker with lead * Implantation of a multi-site pacemaker * Implantation of a single-chamber endovascular defibrillator * Implantation of a dual-chamber endovascular defibrillator * Placement of multi-site defibrillator * Typical Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only * Primo Ablation tachycardia by intra nodal re-entry * Accessory pathway ablation * Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined * Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate
Treatment groups
6,600 Participants
are divided into 1 treatment groupGroup A: Patients undergoing radio-guided interventional radiology1 intervention
Trial outcomes
Primary outcomes
1
Radiation dose: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
Total Dose Area Product for the procedure measured in Gy.cm2
Time frame
Day 1 of the intervention2
Total Air Kerma: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Time frame
Day 1 of the intervention3
Total scanning time: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
The total scanning time for the procedure will be measured in seconds
Time frame
Day 1 of the intervention4
Total number of images: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
Quantitative
Time frame
Day 1 of the interventionSecondary outcomes
1
Use of a fixed or mobile C-arm in each of the above 11 interventions
YES /NO
Time frame
Day 1 of the intervention2
Equipment
The make, model and year of commissioning the C-arm used will be recorded.
Time frame
Day 1 of the intervention3
Deviation between the Dose Area Product displayed and measured
The date of the last mandatory Quality Control and deviation between the Dose Area Product displayed and actually measured will be recorded.
Time frame
Day 1 of the intervention4
Deviation between the total air Kerma displayed and measured
The date of the last mandatory Quality Control and deviation between the total air Kerma displayed and actually measured will be recorded.
Time frame
Day 1 of the interventionSponsors and contacts
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Source ClinicalTrials.gov