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

Overview

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.

Interventions

• Procedure 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.

Primary outcome measures

• 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]

Secondary outcome measures (2)

• Quantify the total atrial arrhythmias burden (AF/AT) over a 12-months period [Time frame: 12 months]
• Assess patient distribution according to residual arrhythmias burden after one year [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• CHU de Nice — Nice

Identifiers

NCT: NCT06985901 · 23-API-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗