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Clinical Trials in France / NCT07462910
Recruiting Not applicable

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

NCT07462910 · tracked via the Priya Life Science France tracker
Sponsor
French Cardiology Society
Phase
Not applicable
Started
2026-06-02
Last updated
2026-06-10

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Dynamic fluoroscopy

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. * Possibility of performing a fluoroscopic diaphragmatic evaluation before and after the operation (before discharge from the hospital). * Free, informed and signed consent by the patient before any data collection Exclusion Criteria: * 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. * Evidence of diaphragmatic paralysis on the pre-procedure fluoroscopy loop, defined as: * Cranio-caudal excursion amplitude ≤35 mm on both hemidiaphragms, Or * An asymmetry in contraction amplitude ≥15% between the two sides. * Inability to perform a post-procedure follow-up fluoroscopy (logistical limitation, patient refusal, contraindication to irradiation). * Pregnancy or breastfeeding in progress. * Concurrent participation in another interventional study that may interfere with the objectives of this research. * Major impairment in cognitive function or inability to understand the objectives of the study or sign a valid consent. * Individuals deprived of liberty by judicial or administrative decision. * Adults subject to a legal protection measure (guardianship, curatorship, or judicial protection/safeguard of justice). * Individuals unable to provide informed consent.

Primary outcome measure(s)

  • Diaphragmatic paralysis — 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)
    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.

Trial sites (9)

FacilityCityRegionStatus
Montreal Heart Institute Montreal Canada Not Yet Recruiting
CHRU de Tours - Hôpital Trousseau Chambray-lès-Tours France Not Yet Recruiting
CHU de Lyon - Hôpital Croix-Rousse Lyon France Not Yet Recruiting
Centre Hospitalier de Pau - Hôpital François Mitterrand Pau France Recruiting
CHU de Bordeaux - Hôpital Haut-Lévêque Pessac France Not Yet Recruiting
Centre Cardiologique du Nord Saint-Denis France Not Yet Recruiting
Institut Cardiovasculaire de Strasbourg - Clinique Rhéna Strasbourg France Not Yet Recruiting
Clinique Pasteur Toulouse France Not Yet Recruiting
Auckland City Hospital Auckland New Zealand Not Yet Recruiting

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MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease Recruiting
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Other trials for the same condition

Modified Left Atrial Maze Procedure for Concomitant AF Ablation Enrolling by invitation
Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation. Recruiting
Contribution of Computed Tomography and Cardiac-MRI in Atrial Fibrillation Ablation Recruiting
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07462910 on ClinicalTrials.gov ↗ ← All trials in France