Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.
Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology. The NR-Rythmo Study
Centre Hospitalier Universitaire de Nīmes
6,600 participants
May 1, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria2
- Patient whose procedure does not require X-rays
- Pregnant women
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Interventions
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
Locations(1)
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NCT06507085