Pulsed-field ablation for persistent atrial fibrillation: a multicenter study with implantable monitor follow-up

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

This multicenter interventional study investigates the use of pulsed-field ablation (PFA) to treat persistent atrial fibrillation. Participants must have symptomatic persistent AF lasting more than seven days and meet criteria regarding prior therapies and affiliations. Recurrences will be monitored continuously using an insertable cardiac monitor to provide rigorous outcome assessment. The study aims to determine the efficacy and safety of PFA in this population, with a focus on tissue-specific ablation and reduced collateral risk. Enrollment criteria exclude certain high-risk cardiac conditions and prior ablation outside the cavotricuspid isthmus.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 it's running

• CHU de Nice
  Nice, France Recruiting

Study contacts

• Study coordinator: Sok-Sithikun BUN, MD, PhD
• Email: bun.s@chu-nice.fr
• Phone: 04 92 03 77 33

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pulsed field ablation for atrial fibrillation in underrepresented minority patients

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• Left Atrial Appendage Occlusion and Rhythm Restoration in AF Patients

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• Qidong Yixin Granules to prevent atrial fibrillation returning after ablation

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• FARAPULSE pulsed-field waveform treatment for paroxysmal and persistent atrial fibrillation

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  Recruiting at 3 sites Boston Scientific Corporation · Split and 3 other locations · NCT07444320

• PVI Alone vs PVI Plus PWI and SVCI with PFA in Persistent AF

  This study tests whether adding posterior wall isolation and superior vena cava isolation to pulmonary vein isolation with pulsed-field ablation helps people with persistent atrial fibrillation stay in rhythm.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07405359

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.