Checking the diaphragm after pulsed field ablation for atrial fibrillation
Uses dynamic fluoroscopy to check for diaphragm paralysis in adults treated for atrial fibrillation.
Key facts
- Who runs it
- French Cardiology Society
- Where
- Chambray-lès-Tours, Lyon, Pau, Pessac, Saint-Denis, Strasbourg, and Toulouse, FranceSee the 7 sitesAlso in 2 other countries, 2 sites
- Trial code
- Registry title
- Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
- Status
- Recruiting
- People taking part
- 250 people, planned
- Started
- 2 Jun 2026
- Expected to end
- 31 May 2027
- Type of study
- Interventional
- Treatments tested
- Dynamic fluoroscopy
- Record updated
- 10 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with paroxysmal or persistent atrial fibrillation who are planned for a first ablation with a pulsed field ablation catheter. Their diaphragm is checked by fluoroscopy before and after the procedure.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Paroxysmal or persistent atrial fibrillation, documented by ECG, Holter, or an implanted or connected device.
- Earlier treatment
- No earlier atrial fibrillation ablation. This must be the first ablation, planned as part of routine care.
Main reasons for not taking part
- Known or suspected diaphragm paralysis before the procedure
- Previous atrial fibrillation ablation
- Neuromuscular disease
- Major chest surgery or long-term lung disease that may affect diaphragm movement
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Inability to perform a post-procedure follow-up fluoroscopy (logistical limitation, patient refusal, contraindication to irradiation)
- Concurrent participation in another interventional study that may interfere with the objectives of this research
- 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
- Major impairment in cognitive function or inability to understand the objectives of the study or sign a valid consent
- 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
- Pregnancy or breastfeeding in progress
- 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
Where in France
Also in 2 other countries, 2 sites
- CHRU de Tours - Hôpital TrousseauChambray-lès-Tours, FranceContact: Arnaud BISSON, MDNot yet recruiting
- CHU de Lyon - Hôpital Croix-RousseLyon, FranceContact: Sami FAREH, MDNot yet recruiting
- Centre Hospitalier de Pau - Hôpital François MitterrandPau, FranceContact: Hugues BADER, MDTaking people
- CHU de Bordeaux Hopital Haut levequePessac, FranceContact: Romain TIXIER, MDNot yet recruiting
- Centre Cardiologique du NordSaint-Denis, FranceContact: William ESCANDE, MDNot yet recruiting
- Institut Cardiovasculaire de Strasbourg - Clinique RhénaStrasbourg, FranceContact: Babé BAKOUBOULA, MDNot yet recruiting
- Clinique PasteurToulouse, FranceContact: Serge BOVEDA, MDNot yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- InterventionTreatment being tested
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.
Treatment: Dynamic fluoroscopy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation Prospective Multicentre Study on the Evaluation of the Incidence of Diaphragmatic Paralysis After Pulsed Field Ablation Procedures to Treat Atrial Fibrillation
- Plain-language title
- Checking the diaphragm after pulsed field ablation for atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 10 June 2026