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Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
Sponsor: French Cardiology Society
Summary
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.
Official title: Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation Prospective Multicentre Study on the Evaluation of the Incidence of Diaphragmatic Paralysis After Pulsed Field Ablation Procedures to Treat Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2026-05-01
Completion Date
2027-05-31
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Dynamic fluoroscopy
Fluoroscopic loop recording or continuous digital scopy of the thoracic window, over at least one complete breathing cycle at maximum amplitude.
Locations (9)
Montreal Heart Institute
Montreal, Canada
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, France
CHU de Lyon - Hôpital Croix-Rousse
Lyon, France
Centre Hospitalier de Pau - Hôpital François Mitterrand
Pau, France
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, France
Centre Cardiologique du Nord
Saint-Denis, France
Institut Cardiovasculaire de Strasbourg - Clinique Rhéna
Strasbourg, France
Clinique Pasteur
Toulouse, France
Auckland City Hospital
Auckland, New Zealand