Diaphragmatic function after pulsed field ablation for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

DEFINE-PFA is a prospective, multicenter study enrolling about 250 adults with paroxysmal or persistent atrial fibrillation undergoing pulsed field ablation. Each participant has dynamic fluoroscopy before and after the ablation to monitor diaphragmatic movement, with a follow-up fluoroscopy at 3 months if there is a significant decrease in diaphragmatic amplitude. The primary endpoint looks for inter-hemidiaphragmatic asymmetry during a single inspiratory effort, using the contralateral diaphragm as an internal reference to minimize measurement bias. Pre-procedure imaging ensures there is no baseline asymmetry. Eligible centers include sites in France, New Zealand, and Canada, with sponsorship from the French Cardiology Society and collaborators focused on imaging and electrophysiology.

Why it matters

Who can join: the full rules

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's running

• Centre Hospitalier de Pau - Hôpital François Mitterrand
  Pau, France Recruiting
• Montreal Heart Institute
  Montreal, Canada Not yet recruiting
• CHRU de Tours - Hôpital Trousseau
  Chambray-lès-Tours, France Not yet recruiting
• CHU de Lyon - Hôpital Croix-Rousse
  Lyon, France Not yet recruiting
• CHU de Bordeaux - Hôpital Haut-Lévêque
  Pessac, France Not yet recruiting
• Centre Cardiologique du Nord
  Saint-Denis, France Not yet recruiting

Study contacts

• Study coordinator: Tessa BERGOT, MSc
• Email: tessa.bergot@sfcardio.fr
• Phone: +33144907033

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.