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Status:

RECRUITING

Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology.

Lead Sponsor:

Centre Hospitalier Universitaire de Nīmes

Conditions:

Radiology, Interventional

Heart Rhythm Disorders

Eligibility:

All Genders

18+ years

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...

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 pro...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

May 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

6600 Patients enrolled

Trial Details

Trial ID

NCT06507085

Start Date

May 1 2024

End Date

January 1 2026

Last Update

July 18 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Nîmes University Hospital

Nîmes, Gard, France, 30029