NCT07462910Recruiting
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
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
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 2 Mar 2026
- Start date
- 2 Jun 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- French Cardiology Society
- Diseases
- Atrial fibrillation
- NCT number
- NCT07462910
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 2 Jun 2026 to the primary completion date, 31 May 2027
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| CHRU de Tours - Hôpital Trousseau Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Not yet recruiting |
| CHU de Lyon - Hôpital Croix-Rousse Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Centre Hospitalier de Pau - Hôpital François Mitterrand Coordinator of this site? Confirm its status | Pau | France | Recruiting |
| CHU de Bordeaux Hopital Haut leveque Coordinator of this site? Confirm its status | Pessac | France | Not yet recruiting |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Not yet recruiting |
| Institut Cardiovasculaire de Strasbourg - Clinique Rhéna Coordinator of this site? Confirm its status | Strasbourg | France | Not yet recruiting |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.