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NCT Number: NCT06985901

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

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.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Persistent atrial fibrillation ablation using Pulsed-field ablation

Procedure

Pulmonary vein isolation with pulsed-field ablation coupled with 3D electroanatomic mapping. Follow-up with insertable cardiac monitor.

Primary outcomes

  1. To assess the 12 month-efficacy (absence of atrial arrhythmias recurrences based upon ICM follow-up) after PVI using PFA in patients with persistent AF.

    Time frame: 12 months

    Efficacy will be assessed by the absence of AF/AT (episodes > 2min) recurrences during a 12-month follow-up period (clinical success) based upon continuous monitoring (ICM). Recurrence will be defined as any AF/AT episode > 2 min (detected by ICM) after the 2-month blanking period.

Secondary outcomes

  1. Quantify the total atrial arrhythmias burden (AF/AT) over a 12-months period

    Time frame: 12 months

    Efficacy will be assessed by total AF/AT burden (recurrence as defined in the main criterion of evaluation), recorded by the ICM, and defined as the total period of time spent in AF/AT over the 12-month follow-up period (after the 2-month blanking period; assessment period of 10 months)

  2. Assess patient distribution according to residual arrhythmias burden after one year

    Time frame: 12 months

    Residual AF/AT burden will be categorized into 4 groups: 0-0,1%; >0,1%-1%; >1-10%; >10% of the follow-up period. After calculation of the total AF/AT burden of each patient at M12, he will be classified into one of the above categories.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura VIALE-TRIGLIA

CONTACT

[email protected]

04 92 03 24 46 ext. +33

Sok-Sithikun BUN, MD, PhD

CONTACT

[email protected]

04 92 03 77 33 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PersAF ICM

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
May 22, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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