Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.
- Conditions
- Radiology, InterventionalHeart Rhythm Disorders
- Interventions
- Radiation: Radio-guided interventions to correct heart rhythm disorders
- Registration Number
- NCT06507085
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief 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.
- Detailed Description
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.
To provide healthcare professionals with an optimization tool, the International Commission on Radiological Protection (ICRP) introduced the concept of diagnostic reference levels (DRLs) in 1997. For the first time, in 2019, the French Authority on Nuclear Safety published DRLs 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 procedudures under CT guidance were also defined in 2020 following a national multicentre 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 diagnostic reference levels for radioguided interventional procedures in rhythmology for the following acts:
* Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical acts)
* Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts)
* Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
* Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
* Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
* Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
* Typical Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
* Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
* Accessory pathway ablation (DEPF 005 according to the common French classification for medical acts)
* Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
* 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) Secondaires objectives include the evaluation of interventional practices for each procedure performed regarding the use of a fixed or mobile C-arm, the make, model and year of installation of the equipment used, deviation at last external quality control between displayed and measured dose area product and, if available, between displayed and measured Kair, the lowest/highest scan rates used during the procedure, use of graphy,lowest/highest scan rate(s) used during procedures, use of collimation during procedures, use of a 3D mapping system, the type of technique used for an ablation procedure, if used, the use of a cage-type radiation protection system during the procedure, cone beam computed tomography performed during procedure, CT scan before the procedure, duration of the procedure and the experience of the operator performing the procedure.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6600
- Adult male/female patient (≥ 18 years)
- Body Mass Index (BMI) between 18 and 35 kg/m².
- Patient to benefit from one of the following procedures:
Placement of single-chamber pacemaker with lead (DELF 007 according to CCAM) Dual-chamber pacemaker insertion with lead (DELF 005 according to CCAM) Multi-site pacemaker placement (DELF 001 and/or DELF 015 according to CCAM) Placement of single-chamber endovascular defibrillator (DELF 013 according to CCAM) Placement of dual-chamber endovascular defibrillator (DELF 015 according to CCAM) Placement of multi-site defibrillator (DELF 020 or DELF 014 according to CCAM) Primo Ablation Typical Atrial Flutter: Cavotricuspid Isthmus only (DEPF 012 according to CCAM) Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to CCAM) Accessory pathway ablation (DEPF 005 according to CCAM) Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per CCAM) Primo Ablation Persistent atrial fibrillation (4 pulmonary veins ± lines ± substrate; DEPF 033 ± DEPF 014 ± DENF 018 ± DEPF 012 according to CCAM)
- Patient whose procedure does not require X-rays
- Pregnant women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing radio-guided interventional radiology Radio-guided interventions to correct heart rhythm disorders All patients undergoing interventional radiology to correct heart rhythm disorders
- Primary Outcome Measures
Name Time Method Radiation dose: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts) Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
Total scanning time: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
Radiation dose: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts) Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
Total number of images: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts) Day 1 of the intervention Quantitative
Radiation dose: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts) Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
Total scanning time: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
Radiation dose : Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts) Day 1 day of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
Total scanning time: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
Radiation dose: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts) Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: pathway ablation (DEPF 005 according to the common French classification for medical acts) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total number of images: pathway ablation (DEPF 005 according to the common French classification for medical acts) Day 1 of the intervention Quantitative
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) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
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) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
Total Air Kerma: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common classification for medical acts) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total Air Kerma : Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
Total number of images: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts) Day 1 of the intervention Quantitative
Total number of images: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts) Day 1 of the intervention Quantitative
Total scanning time: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
Total scanning time: pathway ablation (DEPF 005 according to the common French classification for medical acts) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
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) Day 1 of the intervention Quantitative
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) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
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) Day 1 of the intervention Quantitative
Total number of images: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts) Day 1 of the intervention Quantitative
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) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
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) Day 1 of the intervention Quantitative
Total Air Kerma: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total number of images: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts Day 1 of the intervention Quantitative
Total Air Kerma: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Radiation dose: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures) Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
Total scanning time: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures) Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
Radiation dose: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
Total scanning time: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts Day 1 of the intervention The total scanning time for the procedure will be measured in seconds
Total number of images: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures) Day 1 of the intervention Quantitative
Total Air Kerma: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total Air Kerma: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total number of images: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts) Day 1 of the intervention Quantitative
Radiation dose: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts) Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total Air Kerma: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts) Day 1 of the intervention The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Radiation dose: pathway ablation (DEPF 005 according to the common French classification for medical acts) Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
Radiation dose: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts) Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
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) Day 1 of the intervention Total Dose Area Product for the procedure measured in Gy.cm2
- Secondary Outcome Measures
Name Time Method Equipment Day 1 of the intervention The make, model and year of commissioning the C-arm used will be recorded.
Deviation between the total air Kerma displayed and measured Day 1 of the intervention The date of the last mandatory Quality Control and deviation between the total air Kerma displayed and actually measured will be recorded.
Use of a fixed or mobile C-arm in each of the above 11 interventions Day 1 of the intervention YES /NO
CT scan before a paroxysmal atrial fibrillation ablation procedure ? Day 1 of the intervention YES/NO
Lowest/highest fluoroscopy frame rates Day 1 of the intervention The lowest/highest frame rates used during fluoroscopy procedures will be measured in p/s
Lowest /highest fluorography rates Day 1 of the intervention The lowest/highest frame rates used during fluorography procedures will be measured in p/s
Technique used for ablation Day 1 of the intervention The type of technique used for ablation procedures will be recorded
Rhythmologist's experience Day 1 of the intervention The number of years of experience of the surgeon who performed the procedure will be recorded in years
Deviation between the Dose Area Product displayed and measured Day 1 of the intervention The date of the last mandatory Quality Control and deviation between the Dose Area Product displayed and actually measured will be recorded.
Use of a 3D mapping system during each of the above 11 procedures ? Day 1 of the intervention YES/NO
Use of a collective radiation protection system during each of the above 11 procedures ? Day 1 of the intervention YES/NO
Duration of each of the above procedures Day 1 of the intervention The duration of each of the above procedures will be recorded in minutes
Cone Beam Computed Tomography performed during any of the procedures above ? Day 1 of the intervention YES/NO
Use of collimation during each of the above 11 procedures ? Day 1 of the intervention YES/NO
Use of fluorography Day 1 of the intervention YES/NO
Trial Locations
- Locations (1)
Nîmes University Hospital
🇫🇷Nîmes, Gard, France