Pulsed Field Ablation for Atrial Fibrillation

Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation

Recruiting N/A Interventional Study
Atrial Fibrillation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
250 (estimated)
Sponsor
French Cardiology Society · Other
Who this trial is looking for

This trial is looking for adults with atrial fibrillation who are interested in a new treatment called Pulsed Field Ablation. Participants will undergo a procedure and have their diaphragm evaluated before and after to check for any complications.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 18 years or older.
  • I have been diagnosed with atrial fibrillation.
  • I need an ablation procedure as part of my care.
  • I am having my first ablation procedure.
  • I can have a diaphragm evaluation before and after the procedure.
  • I have signed consent to participate.

You may not be able to join if

  • I have a history of diaphragmatic paralysis.
  • I have had an atrial fibrillation ablation before.
  • I have a history of neuromuscular disease.
  • I have had major thoracic surgery or chronic lung problems.
  • I have signs of diaphragmatic paralysis in a pre-procedure evaluation.
  • I cannot do the follow-up evaluation after the procedure.
  • I am currently pregnant or breastfeeding.
  • I cannot give informed consent.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 report…
Trial Locations
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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). * I…
Contacts

Tessa BERGOT, MSc

+33144907033

tessa.bergot@sfcardio.fr

CONTACT