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Can we make heart procedures safer by tracking X-Ray doses?
NCT ID NCT06507085
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This study aims to establish national reference levels for radiation exposure during X-ray guided procedures to correct heart rhythm disorders, such as pacemaker insertions and ablations. Researchers will collect radiation dose data from over 4,000 adult patients undergoing these procedures across multiple centers. The goal is to define standard benchmarks that can help hospitals monitor and reduce radiation exposure, improving safety for patients and staff.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation exposure during X-ray guided heart rhythm procedures
- What this could lead to
- If successful, this could establish national safety benchmarks for radiation doses in heart rhythm procedures, helping to minimize patient exposure and improve procedural safety.
- What could go wrong
- This is an observational study, so it won't test a new treatment. The results may vary across centers and technologies, and setting benchmarks doesn't directly change outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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4,219 people
The number who actually took part.
- Started
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May 2024
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Study population: All patients benefitting from a rhythmology procedure to be performed among the procedures defined in the inclusion criteria.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Nîmes University Hospital
Nîmes, Gard, 30029, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.