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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

NCT ID: NCT06985901

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Symptomatic persistent atrial fibrillation

Group Type EXPERIMENTAL

Persistent atrial fibrillation ablation using Pulsed-field ablation

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sok-Sithikun BUN, MD, PhD

Role: CONTACT

[email protected]
04 92 03 77 33 ext. +33

Laura VIALE-TRIGLIA

Role: CONTACT

[email protected]
04 92 03 24 46 ext. +33

Other Identifiers

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23-API-03

Identifier Type: -

Identifier Source: org_study_id