Ground-BrEAking Electroporation-based inTervention for Atrial Fibrillation treatment (BEAT AF)

Informations projet

BEAT AF

N° de convention de subvention: 945125

DOI

10.3030/945125

Projet clôturé

Date de signature de la CE 18 Janvier 2021

Date de début 1 Mars 2021

Date de fin 28 Février 2026

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 6 767 266,51

Contribution de l’UE

€ 6 093 743,00

Coordonné par

UNIVERSITE DE BORDEAUX
France

Periodic Reporting for period 3 - BEAT AF (Ground-BrEAking Electroporation-based inTervention for Atrial Fibrillation treatment (BEAT AF))

Période du rapport: 2024-03-01 au 2025-08-31

Résumé du contexte et des objectifs généraux du projet

Atrial fibrillation (AF), the most common arrhythmia, accounts for 1/3rd of cardiovascular expenses, with over 10 million affected in Europe. In addition to significant impact on quality of life, AF exposes patients to stroke, heart failure, dementia and death. This arrhythmia is characterized by abnormalities in electrical impulse formation and conduction within the heart.
Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, preventing arrhythmia recurrences. Catheter ablation of AF uses either radio frequency (RF) or cryothermal (cryo) energy. Common to these thermal energy sources is the fact that these modalities ablate all tissue types indiscriminately, exposing patients to some complications. The ablation procedure remains long, requires skills and expertise, and has a limited success rate, mostly because of non-durable lesions after PVI implying frequent redo procedures. These energies are associated with rare but severe complications due to their thermal nature. It remains suboptimal with safety and efficacy issues, and can only be delivered by highly trained specialists. Complications and duration of the procedure itself directly affect the time spent in the operating theatre and hospital as well as associated costs.
The goal of BEAT AF is to disrupt AF ablation by achieving durable PVI with permanent, coalescent and transmural ablation lesions using Pulsed Electric Field (PEF) energy. PEF is non-thermal and creates nanoscale pores in cell membranes. This energy has some tissue selectivity: cardiac cells are highly sensitive to PEF unlike phrenic and esophageal cells. BEAT AF aims to demonstrate that PEF ablation is faster, more effective and safer (tissue selectivity) than RF or cryo ablation. For this purpose, two distinct randomized clinical trials will be conducted: 1) to provide first comparative evidence of the superiority of PEF over RF on the rate of 1-year recurrence for paroxysmal AF, and 2) to provide first evidence of potential efficacy of PEF on the rate of 1-year clinical recurrence for persistent AF. The BEAT AF consortium gathers 9 European renowned clinical centres (France, Czech Republic, Germany, Austria, Belgium) to set the ground for large trials and contribute to decrease the huge burden of AF in Europe.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

During the current reporting period, patient enrolment and last-participant last-visit follow-up were successfully completed for both the PAROX-AF and PERS-AF studies, and primary and secondary analyses were initiated. Progress was also made across four associated sub-studies.
Enrolment for the PAROX-AF (paroxysmal AF) study was finalised in mid-January 2024 with 292 participants, while the PERS-AF (persistent AF) study completed enrolment in May 2024 with 83 participants.

Primary results from the PAROX-AF study show that both radiofrequency ablation (RFA) and pulsed-field ablation (PFA) achieve high efficacy, with success rates close to 80% in patients with paroxysmal atrial fibrillation. PFA procedures were generally faster and associated with fewer adverse events. Importantly, PFA reached a high level of clinical efficacy within a very short adoption period, a milestone that took RFA nearly three decades to achieve.

The primary results of the PERS-AF study will be presented in the next reporting period, as the database was locked on November 25th.

Most sub-studies have now included sufficient patients to generate meaningful results. However, Sub-study 7.5 (“Atrial and ventricular function / PV diameter differences between PEF and RF”) was discontinued due to an insufficient number of usable MRI examinations (fewer than 10, with only ~3 of adequate quality). The planned analysis is therefore not publishable, and efforts will be redirected towards other sub-studies and a pulmonary-vein-stenosis imaging analysis instead.

In the meantime, BEAT AF has strengthened its public outreach activities, especially toward patients, who are at the heart of this clinical trial. Over the past 18 months, the communication and dissemination team has focused on sharing clinical trial results with patients in a clear and meaningful way. As part of this effort, patients were included in our third face-to-face meeting in Graz, and a series of flash sessions, open to the public, was organised to facilitate broader engagement and understanding. This collaborative approach has led to a joint strategy to co-publish lay summaries derived from the project’s scientific publications.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

BEAT AF addresses a widespread non-communicable, chronic medical condition that not only constitutes a significant burden on the health and quality of life for the concerned patients, but also poses significant pressure on healthcare system through:
a) long-term pharmacological treatment of AF, treatment of resulting co-morbidities and management of complications (e.g. hospitalizations, emergency care), and
b) costs and complexity of catheter ablation treatment.
By replacing routine thermal PVI with superior, safer and way easier to use PEF energy for cardiac ablation, BEAT AF implements an innovative and effective healthcare intervention providing superior care to more AF patients. Over the last 30 years, no new technology has reached this level of hope in the field. The BEAT AF partners are very excited to participate in a landmark effort!
BEAT AF trials aim at reporting improved hard outcomes, offering an ultra-rapid durable PVI with excellent durable safety to patients. We do believe that among other major clinical benefits, it will completely change patients’ experience and facilitate their decision process to undergo ablation, allowing for earlier ablation procedures.
BEAT AF will pave the way for widespread acceptance of the new technology and drive establishment of PEF ablation for AF in clinical practice within 3 to 4 years. Outcomes for patients and disease burden, both in terms of population access to PEF ablation for AF as well as disease progression and quality-of-life for the individual patient will be greatly improved.
One of BEAT AF’s goals is to establish PEF ablation for AF in medical guidelines for the treatment of these patients. To do so we will provide evidence-based medicine through our two clinical studies and preliminary findings on potential reduction in healthcare costs (e.g. all-cause rehospitalizations, cardiovascular rehospitalizations for AF related and non–AF related, redo procedures, time spent under anti-arrhythmic drugs). Ultimately, this will provide a safer, and more (cost-) effective way of treating patients with atrial fibrillation.

The BEAT-AF visual identity