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Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06507085
Acronym
NR-Rythmo
Enrollment
4219
Registered
2024-07-18
Start date
2024-05-01
Completion date
2025-09-29
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rhythm Disorders, Radiology, Interventional

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.

Interventions

RADIATIONRadio-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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 interventionQuantitative
Total scanning time: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical actsDay 1 of the interventionThe total scanning time for the procedure will be measured in seconds
Total number of images: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical actsDay 1 of the interventionQuantitative
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 interventionTotal Dose Area Product for the procedure measured in Gy.cm2
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 interventionThe total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
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 interventionThe 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 interventionQuantitative
Radiation dose: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)Day 1 of the interventionTotal Dose Area Product for the procedure measured in Gy.cm2
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 interventionThe 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 interventionThe total scanning time for the procedure will be measured in seconds
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 interventionQuantitative
Radiation dose: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)Day 1 of the interventionTotal Dose Area Product for the procedure measured in Gy.cm2
Total Air Kerma: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common classification for medical acts)Day 1 of the interventionThe total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
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 interventionThe total scanning time for the procedure will be measured in seconds
Total Air Kerma: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical actsDay 1 of the interventionThe total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
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 interventionTotal Dose Area Product for the procedure measured in Gy.cm2
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 interventionThe 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 interventionThe 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 interventionQuantitative
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 interventionTotal 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 interventionThe total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
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 interventionThe total scanning time for the procedure will be measured in seconds
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 interventionQuantitative
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 interventionTotal Dose Area Product for the procedure measured in Gy.cm2
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 interventionThe total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
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 interventionThe total scanning time for the procedure will be measured in seconds
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 interventionQuantitative
Radiation dose: pathway ablation (DEPF 005 according to the common French classification for medical acts)Day 1 of the interventionTotal 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 interventionThe total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
Total scanning time: pathway ablation (DEPF 005 according to the common French classification for medical acts)Day 1 of the interventionThe total scanning time for the procedure will be measured in seconds
Total number of images: pathway ablation (DEPF 005 according to the common French classification for medical acts)Day 1 of the interventionQuantitative
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 interventionTotal Dose Area Product for the procedure measured in Gy.cm2
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 interventionThe total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
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 interventionThe 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 interventionQuantitative
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 interventionTotal Dose Area Product for the procedure measured in Gy.cm2
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 interventionThe total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
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 interventionThe 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 interventionQuantitative
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 interventionTotal Dose Area Product for the procedure measured in Gy.cm2
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 interventionThe total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy
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 interventionThe 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 interventionQuantitative
Radiation dose: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical actsDay 1 of the interventionTotal Dose Area Product for the procedure measured in Gy.cm2

Secondary

MeasureTime frameDescription
Use of fluorographyDay 1 of the interventionYES/NO
Lowest /highest fluorography ratesDay 1 of the interventionThe lowest/highest frame rates used during fluorography procedures will be measured in p/s
Use of collimation during each of the above 11 procedures ?Day 1 of the interventionYES/NO
Use of a 3D mapping system during each of the above 11 procedures ?Day 1 of the interventionYES/NO
Technique used for ablationDay 1 of the interventionThe type of technique used for ablation procedures will be recorded
Use of a collective radiation protection system during each of the above 11 procedures ?Day 1 of the interventionYES/NO
Cone Beam Computed Tomography performed during any of the procedures above ?Day 1 of the interventionYES/NO
CT scan before a paroxysmal atrial fibrillation ablation procedure ?Day 1 of the interventionYES/NO
Duration of each of the above proceduresDay 1 of the interventionThe duration of each of the above procedures will be recorded in minutes
Rhythmologist's experienceDay 1 of the interventionThe number of years of experience of the surgeon who performed the procedure will be recorded in years
Use of a fixed or mobile C-arm in each of the above 11 interventionsDay 1 of the interventionYES /NO
EquipmentDay 1 of the interventionThe make, model and year of commissioning the C-arm used will be recorded.
Deviation between the Dose Area Product displayed and measuredDay 1 of the interventionThe date of the last mandatory Quality Control and deviation between the Dose Area Product displayed and actually measured will be recorded.
Deviation between the total air Kerma displayed and measuredDay 1 of the interventionThe date of the last mandatory Quality Control and deviation between the total air Kerma displayed and actually measured will be recorded.
Lowest/highest fluoroscopy frame ratesDay 1 of the interventionThe lowest/highest frame rates used during fluoroscopy procedures will be measured in p/s

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPierre François Winum, Dr.

Nîmes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026