NCT06507085

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

July 3, 2024

Last Update Submit

July 11, 2024

Conditions

Radiology, InterventionalHeart Rhythm Disorders

Outcome Measures

Primary Outcomes (44)

  • Radiation dose: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • Total Air Kerma: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • Total scanning time: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • Total number of images: Insertion of a single-chamber pacemaker with lead (DELF 007 according to the common French classification for medical procedures)

    Quantitative

    Day 1 of the intervention

  • Radiation dose: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • Total Air Kerma: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • Total scanning time: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • Total number of images: Insertion of a dual-chamber pacemaker with lead (DELF 005 according to the common French classification for medical acts

    Quantitative

    Day 1 of the intervention

  • Radiation dose: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • Total Air Kerma: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • Total scanning time: Implantation of a multi-site pacemaker (DELF 001 and/or DELF 015 according to the common French classification for medical acts)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • 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)

    Quantitative

    Day 1 of the intervention

  • Radiation dose: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • Total Air Kerma: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • Total scanning time: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • Total number of images: Implantation of a single-chamber endovascular defibrillator (DELF 013 according to the common French classification for medical acts)

    Quantitative

    Day 1 of the intervention

  • Radiation dose: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • Total Air Kerma: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common classification for medical acts)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • Total scanning time: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • Total number of images: Implantation of a dual-chamber endovascular defibrillator (DELF 015 according to the common French classification for medical acts)

    Quantitative

    Day 1 of the intervention

  • Radiation dose: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • Total Air Kerma : Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • Total scanning time: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • Total number of images: Placement of multi-site defibrillator (DELF 020 or DELF 014 according to the common French classification for medical acts)

    Quantitative

    Day 1 of the intervention

  • Radiation dose : Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 day of the intervention

  • Total Air Kerma: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • Total scanning time: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • Total number of images: Primary Atrial Flutter Ablation: Cavotricuspid Isthmus only (DEPF 012 according to the common French classification for medical acts)

    Quantitative

    Day 1 of the intervention

  • Radiation dose: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • Total Air Kerma: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • Total scanning time: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • Total number of images: Primo Ablation tachycardia by intra nodal re-entry (DEPF 010 according to the common French classification for medical acts)

    Quantitative

    Day 1 of the intervention

  • Radiation dose: pathway ablation (DEPF 005 according to the common French classification for medical acts)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • Total Air Kerma: pathway ablation (DEPF 005 according to the common French classification for medical acts)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • Total scanning time: pathway ablation (DEPF 005 according to the common French classification for medical acts)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • Total number of images: pathway ablation (DEPF 005 according to the common French classification for medical acts)

    Quantitative

    Day 1 of the intervention

  • Radiation dose: Paroxysmal atrial fibrillation ablation (4 pulmonary veins only, all technologies combined; DEPF 033 as per the common French classification for medical acts)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • 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)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • 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)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • 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)

    Quantitative

    Day 1 of the intervention

  • 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)

    Total Dose Area Product for the procedure measured in Gy.cm2

    Day 1 of the intervention

  • 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)

    The total Air Kerma for the procedure will be measured at the interventional reference point (Kair) in Gy

    Day 1 of the intervention

  • 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)

    The total scanning time for the procedure will be measured in seconds

    Day 1 of the intervention

  • 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)

    Quantitative

    Day 1 of the intervention

Secondary Outcomes (15)

  • Use of a fixed or mobile C-arm in each of the above 11 interventions

    Day 1 of the intervention

  • Equipment

    Day 1 of the intervention

  • Deviation between the Dose Area Product displayed and measured

    Day 1 of the intervention

  • Deviation between the total air Kerma displayed and measured

    Day 1 of the intervention

  • Lowest/highest fluoroscopy frame rates

    Day 1 of the intervention

  • +10 more secondary outcomes

Study Arms (1)

Patients undergoing radio-guided interventional radiology

All patients undergoing interventional radiology to correct heart rhythm disorders

Radiation: Radio-guided interventions to correct heart rhythm disorders

Interventions

Radio-guided interventions to correct heart rhythm disordersRADIATION

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

Patients undergoing radio-guided interventional radiology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population: All patients benefitting from a rhythmology procedure to be performed among the procedures defined in the inclusion criteria.

You may qualify if:

  • 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)

You may not qualify if:

  • Patient whose procedure does not require X-rays
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nîmes University Hospital

Nîmes, Gard, 30029, France

RECRUITING

Related Publications (6)

  • Amara W, Socie P, Renault C, Taieb J. [Where are done electrophysiology procedures in France and what is the expected evolution ?]. Ann Cardiol Angeiol (Paris). 2022 Nov;71(5):294-298. doi: 10.1016/j.ancard.2022.08.010. French.

    PMID: 36424019BACKGROUND

  • Etard C, Bigand E, Salvat C, Vidal V, Beregi JP, Hornbeck A, Greffier J. Patient dose in interventional radiology: a multicentre study of the most frequent procedures in France. Eur Radiol. 2017 Oct;27(10):4281-4290. doi: 10.1007/s00330-017-4780-5. Epub 2017 Mar 13.

    PMID: 28289939BACKGROUND

  • 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.

    PMID: 32361774BACKGROUND

  • 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.

    PMID: 19608487BACKGROUND

  • 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.

    PMID: 8911634BACKGROUND

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

    PMID: 12685758BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre François Winum, Dr.

    Nîmes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joël GREFFIER, Dr.

CONTACT

+334.66.68.40.68joel.greffier@chu-nimes.fr

Anissa MEGZARI

CONTACT

0466684236drc@chu-nimes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 18, 2024

Study Start

May 1, 2024

Primary Completion

April 30, 2025

Study Completion

January 1, 2026

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations

FR(1)