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Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.

NCT06507085 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 6600

Last updated 2024-07-18

No results posted yet for this study

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.

Conditions

  • Radiology, Interventional
  • Heart Rhythm Disorders

Interventions

RADIATION

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Pierre François Winum, Dr. · Nîmes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-04-30
Completion
2026-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06507085 on ClinicalTrials.gov