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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Dynamic fluoroscopy

    Procedure/Surgery

    Fluoroscopic loop recording or continuous digital scopy of the thoracic window, over at least one complete breathing cycle at maximum amplitude.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day1: Before the Pulsed Field Ablation and after the Pulsed Field Ablation (at hospital discharge between 2 and 30 hours after ablation, according to a rigorously standardized protocol in all participating centres)

Secondary outcomes

1

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.

Time frame
At 3 months
2

Evaluation of symptoms associated with diaphragmatic paralysis

Presence / absence of symptoms : dyspnea, discomfort on inspiration, decreased physical capacity, sleep disturbances.

Time frame
Day 1, at 3 months
3

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.

Time frame
Day1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

French Cardiology Society

Lead sponsor

Circle Safe

Collaborator

IHU Lyric

Collaborator

ADIMEP

Collaborator