Establishing reference levels for X-ray use in heart rhythm procedures
Dosimetric Reference Levels for Radioguided Interventional Procedures in Rhythmology. The NR-Rythmo Study
This study is testing new safety standards for X-ray use during heart rhythm procedures like pacemaker placements and ablations to keep patients safe while getting effective treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nîmes, Gard) |
| Trial ID | NCT06507085 on ClinicalTrials.gov |
What this trial studies
This study aims to define standard national dosimetric reference levels for radioguided interventional procedures in rhythmology, addressing a gap in existing guidelines. It builds on previous work by the French Authority on Nuclear Safety and other organizations that established reference levels for various interventional radiology and cardiology procedures. By analyzing data from multiple centers, the study seeks to optimize the use of X-rays in these procedures, ensuring patient safety while maintaining effective treatment. The focus is on procedures such as pacemaker and defibrillator placements, as well as ablation techniques for heart rhythm disorders.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require specific heart rhythm interventions such as pacemaker or defibrillator placements.
Not a fit: Patients who do not require radioguided interventional procedures for heart rhythm disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient safety by establishing standardized X-ray exposure levels during heart rhythm interventions.
How similar studies have performed: While similar studies have established reference levels for other interventional procedures, this specific focus on rhythmology is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Patient whose procedure does not require X-rays * Pregnant women
Where this trial is running
Nîmes, Gard
- Nîmes University Hospital — Nîmes, Gard, France (Recruiting)
Study contacts
- Principal investigator: Pierre François Winum, Dr. — Nîmes University Hospital
- Study coordinator: Joël GREFFIER, Dr.
- Email: joel.greffier@chu-nimes.fr
- Phone: +334.66.68.40.68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.