Clinical trial NCT06507085: Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.
Official title: Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology. The NR-Rythmo Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiology, Interventional
Heart Rhythm Disorders
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 6600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiation dose: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
timeFrame: Day 1 of the intervention
measure: Total Air Kerma: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
timeFrame: Day 1 of the intervention
measure: Total scanning time: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
timeFrame: Day 1 of the intervention
measure: Total number of images: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)
timeFrame: Day 1 of the intervention
measure: Radiation dose: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
timeFrame: Day 1 of the intervention
measure: Total Air Kerma: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
timeFrame: Day 1 of the intervention
measure: Total scanning time: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
timeFrame: Day 1 of the intervention
measure: Total number of images: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts
timeFrame: Day 1 of the intervention
measure: Radiation dose: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total Air Kerma: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total scanning time: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: 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)
timeFrame: Day 1 of the intervention
measure: Radiation dose: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total Air Kerma: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total scanning time: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total number of images: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Radiation dose: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total Air Kerma: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total scanning time: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total number of images: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Radiation dose: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total Air Kerma : Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total scanning time: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total number of images: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Radiation dose : Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
timeFrame: Day 1 day of the intervention
measure: Total Air Kerma: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total scanning time: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total number of images: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Radiation dose: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total Air Kerma: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total scanning time: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total number of images: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Radiation dose: pathway ablation (DEPF 005 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total Air Kerma: pathway ablation (DEPF 005 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total scanning time: pathway ablation (DEPF 005 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Total number of images: pathway ablation (DEPF 005 according to the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: Radiation dose: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)
timeFrame: Day 1 of the intervention
measure: 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)
timeFrame: Day 1 of the intervention
measure: 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)
timeFrame: Day 1 of the intervention
measure: 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)
timeFrame: Day 1 of the intervention
measure: 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)
timeFrame: Day 1 of the intervention
measure: 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)
timeFrame: Day 1 of the intervention
measure: 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)
timeFrame: Day 1 of the intervention
measure: 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)
timeFrame: Day 1 of the intervention
Secondary outcomes:
measure: Use of a fixed or mobile C-arm in each of the above 11 interventions
timeFrame: Day 1 of the intervention
measure: Equipment
timeFrame: Day 1 of the intervention
measure: Deviation between the Dose Area Product displayed and measured
timeFrame: Day 1 of the intervention
measure: Deviation between the total air Kerma displayed and measured
timeFrame: Day 1 of the intervention
measure: Lowest/highest fluoroscopy frame rates
timeFrame: Day 1 of the intervention
measure: Use of fluorography
timeFrame: Day 1 of the intervention
measure: Lowest /highest fluorography rates
timeFrame: Day 1 of the intervention
measure: Use of collimation during each of the above 11 procedures ?
timeFrame: Day 1 of the intervention
measure: Use of a 3D mapping system during each of the above 11 procedures ?
timeFrame: Day 1 of the intervention
measure: Technique used for ablation
timeFrame: Day 1 of the intervention
measure: Use of a collective radiation protection system during each of the above 11 procedures ?
timeFrame: Day 1 of the intervention
measure: Cone Beam Computed Tomography performed during any of the procedures above ?
timeFrame: Day 1 of the intervention
measure: CT scan before a paroxysmal atrial fibrillation ablation procedure ?
timeFrame: Day 1 of the intervention
measure: Duration of each of the above procedures
timeFrame: Day 1 of the intervention
measure: Rhythmologist's experience
timeFrame: Day 1 of the intervention
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
state: Gard
Study officials:
affiliation: Nîmes University Hospital
name: Pierre François Winum, Dr.
role: PRINCIPAL_INVESTIGATOR
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