NCT07462910 Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
| NCT ID | NCT07462910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | French Cardiology Society |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2026-06-02 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Romain TIXIER, MD
STUDY CHAIR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT07462910 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07462910 currently recruiting?
Yes, NCT07462910 is actively recruiting participants. Contact the research team at tessa.bergot@sfcardio.fr for enrollment information.
Where is the NCT07462910 trial being conducted?
This trial is being conducted at Montreal, Canada, Chambray-lès-Tours, France, Lyon, France, Pau, France and 5 additional locations.
Who is sponsoring the NCT07462910 clinical trial?
NCT07462910 is sponsored by French Cardiology Society. The principal investigator is Romain TIXIER, MD at University Hospital, Bordeaux. The trial plans to enroll 250 participants.
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