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Tests pulsed-field ablation for persistent atrial fibrillation heart rhythm disorder

Tests a heart procedure called pulsed-field ablation in adults with persistent atrial fibrillation.

Key facts

Who runs it
Centre Hospitalier Universitaire de Nice
Where
Nice, FranceSee the site
Trial code
Registry title
Evaluation of the Efficacy of Pulmonary Vein Isolation by Pulsed-field Ablation in Persistent Atrial Fibrillation: a Multicenter Study With Follow-up by Implantable Cardiac Monitor
Status
Recruiting
People taking part
60 people, planned
Started
13 Apr 2026
Expected to end
13 Apr 2030
Type of study
Interventional
Treatments tested
  • Persistent atrial fibrillation ablation using Pulsed-field ablation
Record updated
11 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with persistent atrial fibrillation who have symptoms, to test a new heart ablation method called pulsed-field ablation.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Symptomatic persistent atrial fibrillation: one continuous episode lasting beyond 7 days. An episode continuous for more than 3 years is not allowed.
Earlier treatment
Anti-arrhythmic drugs did not work, were not tolerated, or the person does not want to take them. No previous atrial ablation outside the cavotricuspid isthmus.

Main reasons for not taking part

  • Pacemaker, defibrillator or implantable cardiac monitor already in place
  • Severe heart valve disease, congenital heart disease or a blood clot in the heart
  • Heart attack, coronary angioplasty, heart surgery, systemic thromboembolic event or pulmonary embolism in the last 6 months
  • Left ventricular ejection fraction of 15% or less, or New York Heart Association stage IV
  • Minor, or under curatorship or guardianship

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Symptomatic persistent AF (continuous episode sustained beyond 7 days)
  • Refractory, intolerant or unwilling to take ADT
  • Signed informed consent
  • Affiliation to medical social coverage; Non inclusion Criteria:
  • Persistent long-term atrial fibrillation with ongoing episode continuous for more than 3 years
  • Left ventricular ejection fraction ≤ 15%
  • Stage IV of the New York Heart Association classification
  • Previous atrial ablation outside the cavotricuspid isthmus
  • Wearer of an implantable electronic cardiac prosthesis (pacemaker or defibrillator; MCI)
  • Hypertrophic heart disease other than hypertensive hypertrophic heart disease
  • Severe valvular heart disease, including the presence of a mechanical mitral valve or any mitral surgery
  • Congenital heart disease, including atrial septal defect, patent foramen ovale treated by percutaneous closure with atrial septal prosthesis
  • Presence of cardiac thrombus
  • Myocardial infarction or percutaneous coronary angioplasty within the last 6 months
  • Cardiac surgery within the last 6 months
  • Systemic thromboembolic event less than 6 months ago
  • Pulmonary embolism less than 6 months ago or pulmonary hypertension requiring specific treatment
  • Inability to read independently
  • Vulnerable patient: minor, patient under curatorship or guardianship

Where in France

  • CHU de NiceNice, FranceContact: Sok-Sithikun Dr BUNTaking people

About the trial

What the trial wants to find out

Atrial fibrillation (AF) is the most common sustained arrhythmia in adult population. According to current guidelines for the management of AF, radiofrequency (RF) ablation (including at least pulmonary vein isolation [PVI]) is a validated therapeutic option for persistent AF. Recently, Pulsed-field ablation (PFA) - a new non-thermal energy - has been used to treat paroxysmal and persistent AF with a high success rate in observational studies. This new technology is based on tissue-specificity on myocardium, avoiding collateral damages on adjacent structures. Before confirming a superiority of PFA over existing thermal energies, prospective studies concerning an exclusive population of persistent AF patients are needed, with rigorous assessment of the recurrences using continuous monitoring (insertable cardiac monitor [ICM]). PFA efficacy using ICM has never been evaluated. Before considering PFA in therapeutic strategies through large-scale randomized studies using rigorous monitoring of recurrences, preliminary studies are needed in a persistent AF population-only. This pilot cohort study will provide solid data of PFA efficacy (using continuous monitoring of recurrences) for future randomized studies.

The group in the trial

  • Symptomatic persistent atrial fibrillationTreatment being tested

    Treatment: Persistent atrial fibrillation ablation using Pulsed-field ablation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of the Efficacy of Pulmonary Vein Isolation by Pulsed-field Ablation in Persistent Atrial Fibrillation: a Multicenter Study With Follow-up by Implantable Cardiac Monitor
Plain-language title
Tests pulsed-field ablation for persistent atrial fibrillation heart rhythm disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 June 2026