Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation

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.

NCT Number	NCT07462910
Lead Sponsor	French Cardiology Society Collaborators: Circle Safe, IHU Lyric, ADIMEP
Conditions	Atrial Fibrillation
Enrollment	250 participants
Start Date	2026-06-02
Primary Completion	2027-05-31 (estimated)
Study Completion	2027-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-10