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

Project description

DEENESFRITPL

A more effective and safer ablation strategy for treating atrial fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia and is usually treated with catheter ablation, using either radio-frequency or cryoablation, scarring the tissue in the heart responsible for sending faulty electrical signals. This approach has a limited success rate with non-durable results and requires skills and expertise. The scope of the EU-funded BEAT AF project is to develop an alternative ablation strategy for a more long-lasting effect on AF symptoms. BEAT AF will employ pulsed electric field (PEF) energy which works by creating nanoscale pores in cell membranes. Researchers will undertake clinical trials to validate the effectiveness and superiority of PEF ablation compared to ablation using radiofrequency or cryothermal energy.

Objective

Atrial fibrillation (AF), the most common arrhythmia, accounts for 1/3rd of Cardiovascular expenses, with over 10 millions affected in Europe. In addition to significant impact on quality of life, AF exposes patients to stroke, heart failure, dementia and death. AF is the most commonly ablated arrhythmia. The Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, preventing recurrences, especially in patients with paroxysmal AF. Catheter ablation of AF uses either radio-frequency (RF) or cryothermal (cryo) energy. Common to these thermal energy sources is their reliance on time-dependent conductive heating/cooling and the fact that these modalities ablate all tissue types indiscriminately. 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. And these energies are associated with rare but severe complications due to their thermal nature. 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. Cardiac cells are highly sensitive to PEF unlike phrenic and oesophageal 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.

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Topic(s)

Call for proposal

H2020-SC1-BHC-2018-2020

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Sub call

H2020-SC1-2020-Two-Stage-RTD

Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITE DE BORDEAUX
Net EU contribution
€ 1 474 812,50
Address
Place pey berland 35
33000 Bordeaux
France

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Region
Nouvelle-Aquitaine Aquitaine Gironde
Activity type
Higher or Secondary Education Establishments
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Other funding
€ 0,00

Participants (8)

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EC signature date 18 January 2021
Last update: 11 September 2023

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Permalink: https://cordis.europa.eu/project/id/945125

European Union, 2023