Descrizione del progetto
Una strategia di ablazione più efficace e sicura per trattare la fibrillazione atriale
La fibrillazione atriale (AF, Atrial Fibrillation) è l’aritmia cardiaca più diffusa e viene generalmente trattata con l’ablazione transcatetere, con impiego di radiofrequenza o crioablazione, che cicatrizza il tessuto cardiaco responsabile dell’invio di segnali elettrici anomali. Tale approccio presenta un tasso di successo limitato con risultati non duraturi e richiede competenze ed esperienza. L’ambito del progetto BEAT AF, finanziato dall’UE, è lo sviluppo di una strategia alternativa di ablazione al fine di ottenere effetti di maggiore durata sui sintomi dell’AF. BEAT AF si avvarrà dell’energia da campo elettrico pulsato che agisce creando pori nanometrici nelle membrane cellulari. I ricercatori condurranno sperimentazioni cliniche per convalidare l’efficacia e la superiorità dell’ablazione con campo elettrico pulsato rispetto a quella che impiega energia da radiofrequenza o criotermica.
Obiettivo
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.
Campo scientifico
- engineering and technologyelectrical engineering, electronic engineering, information engineeringinformation engineeringtelecommunicationsradio technologyradio frequency
- medical and health sciencesclinical medicinecardiologycardiovascular diseasescardiac arrhythmia
- medical and health sciencesbasic medicineneurologydementia
- medical and health sciencesbasic medicineneurologystroke
- social sciencespolitical sciencesgovernment systems
Parole chiave
Programma(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SC1-2020-Two-Stage-RTD
Meccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
33000 Bordeaux
Francia