Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.
NCT Number: NCT06507085
Acronym: NR-Rythmo
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Radiology, Interventional|Heart Rhythm Disorders
Interventions: RADIATION: Radio-guided interventions to correct heart rhythm disorders
Sponsor: Centre Hospitalier Universitaire de Nīmes
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2026-01-01
Locations: Nîmes University Hospital, Nîmes, Gard, 30029, France

Summary:
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.

Primary Outcome Measures: 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, Day 1 of the intervention|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, Day 1 of the intervention|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, Day 1 of the intervention|Total number of images: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures), Quantitative, Day 1 of the intervention|Radiation dose: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts, Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 of the intervention|Total Air Kerma: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts, The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts, The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts, Quantitative, Day 1 of the intervention|Radiation dose: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts), Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 of the intervention|Total Air Kerma: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts), The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts), The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts), Quantitative, Day 1 of the intervention|Radiation dose: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts), Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 of the intervention|Total Air Kerma: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts), The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts), The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts), Quantitative, Day 1 of the intervention|Radiation dose: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts), Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 of the intervention|Total Air Kerma: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common classification for medical acts), The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts), The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts), Quantitative, Day 1 of the intervention|Radiation dose: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts), Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 of the intervention|Total Air Kerma : Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts), The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts), The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts), Quantitative, Day 1 of the intervention|Radiation dose : Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts), Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 day of the intervention|Total Air Kerma: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts), The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts), The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts), Quantitative, Day 1 of the intervention|Radiation dose: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts), Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 of the intervention|Total Air Kerma: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts), The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts), The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts), Quantitative, Day 1 of the intervention|Radiation dose: pathway ablation (DEPF 005 according to the common French classification for medical acts), Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 of the intervention|Total Air Kerma: pathway ablation (DEPF 005 according to the common French classification for medical acts), The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: pathway ablation (DEPF 005 according to the common French classification for medical acts), The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: pathway ablation (DEPF 005 according to the common French classification for medical acts), Quantitative, Day 1 of the intervention|Radiation dose: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts), Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 of the intervention|Total Air Kerma: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts), The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts), The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts), Quantitative, Day 1 of the intervention|Radiation dose: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts), Total Dose Area Product for the procedure measured in Gy.cm2, Day 1 of the intervention|Total Air Kerma: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts), The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy, Day 1 of the intervention|Total scanning time: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts), The total scanning time for the procedure will be measured in seconds, Day 1 of the intervention|Total number of images: Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to the common French classification for medical acts), Quantitative, Day 1 of the intervention
Secondary Outcome Measures: Use of a fixed or mobile C-arm in each of the above 11 interventions, YES /NO, Day 1 of the intervention|Equipment, The make, model and year of commissioning the C-arm used will be recorded., Day 1 of the intervention|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., Day 1 of the intervention|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., Day 1 of the intervention|Lowest/highest fluoroscopy frame rates, The lowest/highest frame rates used during fluoroscopy procedures will be measured in p/s, Day 1 of the intervention|Use of fluorography, YES/NO, Day 1 of the intervention|Lowest /highest fluorography rates, The lowest/highest frame rates used during fluorography procedures will be measured in p/s, Day 1 of the intervention|Use of collimation during each of the above 11 procedures ?, YES/NO, Day 1 of the intervention|Use of a 3D mapping system during each of the above 11 procedures ?, YES/NO, Day 1 of the intervention|Technique used for ablation, The type of technique used for ablation procedures will be recorded, Day 1 of the intervention|Use of a collective radiation protection system during each of the above 11 procedures ?, YES/NO, Day 1 of the intervention|Cone Beam Computed Tomography performed during any of the procedures above ?, YES/NO, Day 1 of the intervention|CT scan before a paroxysmal atrial fibrillation ablation procedure ?, YES/NO, Day 1 of the intervention|Duration of each of the above procedures, The duration of each of the above procedures will be recorded in minutes, Day 1 of the intervention|Rhythmologist's experience, The number of years of experience of the surgeon who performed the procedure will be recorded in years, Day 1 of the intervention