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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrench Cardiology Society

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

Qualifiers

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

Treatments tested in this trial

  • Dynamic fluoroscopy

Treatment groups

250 Participants
are divided into 1 treatment group

Sponsors and collaborators

French Cardiology Society

Lead sponsor

Circle Safe

Collaborator

IHU Lyric

Collaborator

ADIMEP

Collaborator