Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507085
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology The NR-Rythmo Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NR-Rythmo
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 andor 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 lowesthighest scan rates used during the procedure use of graphylowesthighest scan rates 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
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 andor 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 lowesthighest scan rates used during the procedure use of graphylowesthighest scan rates 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None