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 | Not Yet Recruiting

• 1 other identifier: 23-API-03
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

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.

  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.

  12 months

Secondary Outcomes (2)

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

  12 months

• Assess patient distribution according to residual arrhythmias burden after one year

  12 months

Study Arms (1)

Symptomatic persistent atrial fibrillation

EXPERIMENTAL

Procedure: Persistent atrial fibrillation ablation using Pulsed-field ablation

Interventions

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.

Symptomatic persistent atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sok-Sithikun BUN, MD, PhD

CONTACT

04 92 03 77 33; bun.s@chu-nice.fr

Laura VIALE-TRIGLIA

CONTACT

04 92 03 24 46; viale-triglia.l@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-06