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

NCT06985901 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire de Nice

Phase

Not applicable

Started

2026-04-13

Last updated

2026-06-11

Condition(s) studied

Persistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

Persistent atrial fibrillation ablation using Pulsed-field ablation

Persistent atrial fibrillation ablation using Pulsed-field ablation: Pulmonary vein isolation with pulsed-field ablation coupled with 3D electroanatomic mapping. Follow-up with insertable cardiac monitor.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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. — 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.

Trial sites (1)

Facility	City	Region	Status
CHU de Nice	Nice	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06985901 on ClinicalTrials.gov ↗ ← All trials in France