Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
Recruiting
N/AInterventional Study
Atrial Fibrillation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
250 (estimated)
Sponsor
French Cardiology Society · Other
Who this trial is looking for
This trial is looking for adults with atrial fibrillation who are interested in a new treatment called Pulsed Field Ablation. Participants will undergo a procedure and have their diaphragm evaluated before and after to check for any complications.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have been diagnosed with atrial fibrillation.
I need an ablation procedure as part of my care.
I am having my first ablation procedure.
I can have a diaphragm evaluation before and after the procedure.
I have signed consent to participate.
You may not be able to join if
I have a history of diaphragmatic paralysis.
I have had an atrial fibrillation ablation before.
I have a history of neuromuscular disease.
I have had major thoracic surgery or chronic lung problems.
I have signs of diaphragmatic paralysis in a pre-procedure evaluation.
I cannot do the follow-up evaluation after the procedure.
I am currently pregnant or breastfeeding.
I cannot give informed consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Pulsed Field Ablation (PFA) represents a recent advance in the treatment of atrial fibrillation (AF), with a safety profile potentially superior to traditional thermal techniques, such as radiofrequency or cryoablation. Its mechanism of action allows tissue selectivity which in theory limits damage to extracardiac structures. However, several cases of right diaphragmatic paralysis have been report…
Pulsed Field Ablation (PFA) represents a recent advance in the treatment of atrial fibrillation (AF), with a safety profile potentially superior to traditional thermal techniques, such as radiofrequency or cryoablation. Its mechanism of action allows tissue selectivity which in theory limits damage to extracardiac structures. However, several cases of right diaphragmatic paralysis have been reported in the literature after PFA, particularly during applications on the right pulmonary veins, near the right phrenic nerve. The available data are from studies without specific diaphragmatic monitoring. The diagnosis of diaphragmatic paralysis is most often based on chest X-ray, a static examination of limited sensitivity, especially for the detection of incomplete paralysis. To date, no prospective multicentre study has evaluated the incidence of diaphragmatic paralysis after PFA with systematic dynamic imaging, such as fluoroscopy, considered the gold standard for the diagnosis of unilateral paralysis.
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Eligibility Criteria
Inclusion Criteria:
* Men and women aged 18 years or older at the time of signing the consent (age≥ 18).
* Diagnosis of paroxysmal or persistent atrial fibrillation, documented in any type of means: ECG, Holter, invasive monitoring (memories of an implantable device) or not (connected objects).
* I…
Inclusion Criteria:
* Men and women aged 18 years or older at the time of signing the consent (age≥ 18).
* Diagnosis of paroxysmal or persistent atrial fibrillation, documented in any type of means: ECG, Holter, invasive monitoring (memories of an implantable device) or not (connected objects).
* Indication for ablation decided as part of routine care, according to the recommendations of learned societies.
* First, ablation procedure (including pulmonary vein isolation) planned with the use of a commercially available Pulsed Field Ablation catheter.
* Possibility of performing a fluoroscopic diaphragmatic evaluation before and after the operation (before discharge from the hospital).
* Free, informed and signed consent by the patient before any data collection
Exclusion Criteria:
* Known history of diaphragmatic paralysis (right or bilateral) or pre-existing clinical suspicion.
* History of atrial fibrillation ablation.
* History of neuromuscular disease.
* History of major thoracic surgery or chronic pulmonary pathology that may impair diaphragmatic kinetics.
* Evidence of diaphragmatic paralysis on the pre-procedure fluoroscopy loop, defined as:
* Cranio-caudal excursion amplitude ≤35 mm on both hemidiaphragms, Or
* An asymmetry in contraction amplitude ≥15% between the two sides.
* Inability to perform a post-procedure follow-up fluoroscopy (logistical limitation, patient refusal, contraindication to irradiation).
* Pregnancy or breastfeeding in progress.
* Concurrent participation in another interventional study that may interfere with the objectives of this research.
* Major impairment in cognitive function or inability to understand the objectives of the study or sign a valid consent.
* Individuals deprived of liberty by judicial or administrative decision.
* Adults subject to a legal protection measure (guardianship, curatorship, or judicial protection/safeguard of justice).
* Individuals unable to provide informed consent.
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