Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology. (NR-Rythmo)

Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology. The NR-Rythmo Study

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Rhythm Disorders; Radiology, Interventional
• Intervention / Treatment: Radiation: Radio-guided interventions to correct heart rhythm disorders

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.

• Study Type: Observational
• Enrollment (Estimated): 6600

Contacts and Locations

• Study Contact: Name: Anissa MEGZARI; Phone Number: 0466684236; Email: drc@chu-nimes.fr
• Study Contact Backup: Name: Joël GREFFIER, Dr.; Phone Number: +334.66.68.40.68; Email: joel.greffier@chu-nimes.fr

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Recruiting
      • Nîmes University Hospital
      • Contact: Anissa MEGZARI; Phone Number: +33466684236; Email: drc@chu-nimes.fr
      • Contact: Joël GREFFIER, Dr.; Phone Number: +334.66.68.40.68

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population: All patients benefitting from a rhythmology procedure to be performed among the procedures defined in the inclusion criteria.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Patient whose procedure does not require X-rays
• Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients undergoing radio-guided interventional radiology; All patients undergoing interventional radiology to correct heart rhythm disorders

Radiation: Radio-guided interventions to correct heart rhythm disorders; All 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Pierre François Winum, Dr., Nîmes University Hospital

Publications and helpful links

General Publications

• Radiological protection and safety in medicine. A report of the International Commission on Radiological Protection. Ann ICRP. 1996;26(2):1-47. No abstract available. Erratum In: Ann ICRP 1997;27(2):61.
• Amara W, Socie P, Renault C, Taieb J. [Where are done electrophysiology procedures in France and what is the expected evolution ?]. Ann Cardiol Angeiol (Paris). 2022 Nov;71(5):294-298. doi: 10.1016/j.ancard.2022.08.010. French.
• Etard C, Bigand E, Salvat C, Vidal V, Beregi JP, Hornbeck A, Greffier J. Patient dose in interventional radiology: a multicentre study of the most frequent procedures in France. Eur Radiol. 2017 Oct;27(10):4281-4290. doi: 10.1007/s00330-017-4780-5. Epub 2017 Mar 13.
• Greffier J, Ferretti G, Rousseau J, Andreani O, Alonso E, Rauch A, Gillet R, Le Roy J, Cabrol-Faivre L, Douane F, David A, Henry S, Jacques T, Stefanovic X, Decoux E, Lafay F, Pilleul F, Couzon F, Boutet C, Woerly B, Baur P, Sans N, Faruch M, Moussier-Lherm A, Tselikas L, Jacquier A, Bigand E, Pessis E, Teriitehau C, Magnier F, Cassagnes L, Haberlay M, Boutteau D, De Kerviler E, Majorel-Gouthain C, Defez D, Vuillod A, Rouviere O, Hennequin L, Fohlen A, Alwan R, Malakhia A, Aubry S, Dohan A, Eresue-Bony M, Gautier R, Dal R, Dabli D, Hebert T, Kovacs R, Hadid-Beurrier L, Bousson V, Potel M, Barbotteau Y, Michel C, Habib-Geryes B, Andre M, Arnaud T, Bestion N, Ernst O, Monfraix S, Brillet PY, Guiu B, Boussel L, Demonchy M, Beregi JP, Frandon J. National dose reference levels in computed tomography-guided interventional procedures-a proposal. Eur Radiol. 2020 Oct;30(10):5690-5701. doi: 10.1007/s00330-020-06903-9. Epub 2020 May 2. Erratum In: Eur Radiol. 2020 Nov;30(11):6384-6386. doi: 10.1007/s00330-020-06948-w.
• Bar O, Maccia C, Pages P, Blanchard D. A multicentre survey of patient exposure to ionising radiation during interventional cardiology procedures in France. EuroIntervention. 2008 Mar;3(5):593-9. doi: 10.4244/eijv3i5a107.
• Diagnostic reference levels in medical imaging: review and additional advice. Ann ICRP. 2001;31(4):33-52.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: NIMAO/2023-2/JG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No