[Where are done electrophysiology procedures in France and what is the expected evolution ?].
Walid Amara, Pierre Socié, Camille Renault...
https://pubmed.ncbi.nlm.nih.gov/36424019Actively Recruiting
Age: 18Years +
All Genders
ID06507085
Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology. The NR-Rythmo Study
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2024-07-18
6600
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Interventional radiology is widely used to diagnose or treat many medical conditions, but it involves exposure to X-rays, which carry risks. Researchers aim to establish standard national dosimetric reference levels for radioguided interventional procedures in rhythmology, a field focusing on heart rhythm disorders. This study builds on earlier national efforts defining radiation reference levels for other interventional radiology and cardiology procedures but addresses a gap by focusing on rhythmology. The study includes patients undergoing various radio-guided procedures to correct heart rhythm disorders, such as insertion or implantation of single-chamber or dual-chamber pacemakers and defibrillators, multi-site device placements, and different types of ablation for atrial flutter and atrial fibrillation. The study collects detailed data on radiation doses, air kerma, scanning time, image counts, equipment types, fluoroscopy settings, use of 3D mapping, radiation protection systems, and procedure durations. Participants will be monitored during their interventional procedure, with data collected on radiation exposure and procedural details on the day of the intervention. This includes measuring radiation dose parameters, imaging data, and equipment use. Secondary outcomes include evaluating technical factors like fluoroscopy rates and radiation protection. The study follows participants from the intervention day and aims to define diagnostic reference levels to help optimize radiation safety in rhythmology interventions.
CONDITIONS
Brief Title
Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult male or female patient aged 18 years or older
- Body Mass Index (BMI) between 18 and 35 kg/m²
- Scheduled to undergo one of the following procedures: single-chamber pacemaker insertion, dual-chamber pacemaker insertion, multi-site pacemaker implantation, single-chamber endovascular defibrillator implantation, dual-chamber endovascular defibrillator implantation, multi-site defibrillator placement, typical primary atrial flutter ablation, intra nodal re-entry tachycardia ablation, accessory pathway ablation, paroxysmal atrial fibrillation ablation, or persistent atrial fibrillation ablation
You will not qualify if you...
- Procedures that do not require X-rays
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Day 1 of the intervention
Participants who undergo routine radio-guided interventional radiology procedures to correct heart rhythm disorders are observed to collect information on radiation dose, equipment use, and procedural details.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Nîmes University Hospital
Nîmes, Gard, France, 30029
Actively Recruiting
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Research Team
J
Joël GREFFIER, Dr.
A
Anissa MEGZARI
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Patient dose in interventional radiology: a multicentre study of the most frequent procedures in France.
Cécile Etard, Emeline Bigand, Cécile Salvat...
https://pubmed.ncbi.nlm.nih.gov/28289939National dose reference levels in computed tomography-guided interventional procedures-a proposal.
Joël Greffier, Gilbert Ferretti, Julia Rousseau...
https://pubmed.ncbi.nlm.nih.gov/32361774A multicentre survey of patient exposure to ionising radiation during interventional cardiology procedures in France.
Olivier Bar, Carlo Maccia, Pierre Pagès...
https://pubmed.ncbi.nlm.nih.gov/19608487