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NOT YET RECRUITING
NCT07462910
NA

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

Sponsor: French Cardiology Society

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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