Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.

NCT ID: NCT06507085

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 6600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-01-01

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.

Conditions

Radiology, Interventional; Heart Rhythm Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing radio-guided interventional radiology

All patients undergoing interventional radiology to correct heart rhythm disorders

Radio-guided interventions to correct heart rhythm disorders

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre François Winum, Dr.

Role: PRINCIPAL_INVESTIGATOR

Nîmes University Hospital

Locations

Nîmes University Hospital

Nîmes, Gard, France

Site Status: RECRUITING

Countries

France

Central Contacts

Joël GREFFIER, Dr.

Role: CONTACT

joel.greffier@chu-nimes.fr

+334.66.68.40.68

Anissa MEGZARI

Role: CONTACT

drc@chu-nimes.fr

0466684236

Facility Contacts

Joël GREFFIER, Dr.

Role: primary

+334.66.68.40.68

Anissa MEGZARI

Role: backup

drc@chu-nimes.fr

+33466684236

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 28289939 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32361774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19608487 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8911634 (View on PubMed)

Diagnostic reference levels in medical imaging: review and additional advice. Ann ICRP. 2001;31(4):33-52.

Reference Type: BACKGROUND

PMID: 12685758 (View on PubMed)

Other Identifiers

NIMAO/2023-2/JG-01

Identifier Type: -

Identifier Source: org_study_id