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

NCT07462910 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Circle Safe

    collaborator UNKNOWN

  • IHU Lyric

    collaborator UNKNOWN

  • ADIMEP

    collaborator UNKNOWN

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Romain TIXIER, MD · University Hospital, Bordeaux

  • Frédéric FRANCESCHI, MD · CHU Marseille

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Canada
  • France
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07462910 on ClinicalTrials.gov