About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Dynamic fluoroscopy
Procedure/SurgeryFluoroscopic loop recording or continuous digital scopy of the thoracic window, over at least one complete breathing cycle at maximum amplitude.
Treatment groups
Trial outcomes
Primary outcomes
Diaphragmatic paralysis
Post-procedural occurrence of diaphragmatic contraction asymmetry, defined as a ≥15% reduction in the cranio-caudal amplitude of a hemi-diaphragm, relative to the contralateral side, measured by dynamic fluoroscopy during a forced breathing cycle, and absent on pre-procedure fluoroscopy.
Secondary outcomes
Rate of complete or partial recovery of diaphragmatic function at 3 months.
For patient with diaphragmatic paralysis observed at inclusion visit, diaphragmatic contraction asymmetry evaluation will be redo after 3 months.
Evaluation of symptoms associated with diaphragmatic paralysis
Presence / absence of symptoms : dyspnea, discomfort on inspiration, decreased physical capacity, sleep disturbances.
Evaluation of the efficiency of the procedure
Comparison, between patients who experienced diaphragmatic paralysis after ablation and those who did not, of the duration of the procedure (in minutes), the duration of the endoscopy (in minutes), the total number of applications and the type of catheter used.
Sponsors and contacts
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