Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
Recruiting · NCT07462910 · Interventional (participants receive a specific treatment) · Lead sponsor: French Cardiology Society
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
9 locations listed.
- Auckland City Hospital - Auckland, New Zealand
- CHRU de Tours - Hôpital Trousseau - Chambray-lès-Tours, France
- CHU de Lyon - Hôpital Croix-Rousse - Lyon, France
- Montreal Heart Institute - Montreal, Canada
- Centre Hospitalier de Pau - Hôpital François Mitterrand - Pau, France
- CHU de Bordeaux - Hôpital Haut-Lévêque - Pessac, France
- Centre Cardiologique du Nord - Saint-Denis, France
- Institut Cardiovasculaire de Strasbourg - Clinique Rhéna - Strasbourg, France
- Clinique Pasteur - Toulouse, France