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

NCT07462910 | Recruiting

• 1 other identifier: 2025-07
• Study Type: interventional
• Target: 250
• Locations: 3 countries
• Sites: 9

Brief 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

Atrial Fibrillation

Keywords

Pulsed Field Ablation; Fluoroscopy; Diaphragmatic monitoring

Outcome Measures

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.

  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 (3)

• Rate of complete or partial recovery of diaphragmatic function at 3 months.

  At 3 months

• Evaluation of symptoms associated with diaphragmatic paralysis

  Day 1, at 3 months

• Evaluation of the efficiency of the procedure

  Day1

Study Arms (1)

Intervention

EXPERIMENTAL

Systematic observation of an additional examination (dynamic fluoroscopy) performed before and after a Pulsed Field Ablation procedure, as part of the standard management of atrial fibrillation.

Procedure: Dynamic fluoroscopy

Interventions

Dynamic fluoroscopy PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• French Cardiology Society: lead
• Circle Safe: collaborator
• IHU Lyric: collaborator
• ADIMEP: collaborator

Study Sites (9)

Montreal Heart Institute

Montreal, QC H1T 1C8, Canada

NOT YET RECRUITING

CHRU de Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170, France

NOT YET RECRUITING

CHU de Lyon - Hôpital Croix-Rousse

Lyon, 69004, France

NOT YET RECRUITING

Centre Hospitalier de Pau - Hôpital François Mitterrand

Pau, 64046, France

RECRUITING

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, 33604, France

NOT YET RECRUITING

Centre Cardiologique du Nord

Saint-Denis, 93200, France

NOT YET RECRUITING

Institut Cardiovasculaire de Strasbourg - Clinique Rhéna

Strasbourg, 67000, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, 31300, France

NOT YET RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Romain TIXIER, MD

  University Hospital, Bordeaux

  STUDY CHAIR

• Frédéric FRANCESCHI, MD

  CHU Marseille

  STUDY DIRECTOR

Central Study Contacts

Tessa BERGOT, MSc

CONTACT

+33144907033; tessa.bergot@sfcardio.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, unblinded, non-randomised, multicentre study conducted in hospitals specializing in rhythmology

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7); CA (1); NZ (1)