Comparing pulsed field electroporation and radiofrequency ablation for the treatment of paroxysmal atrial fibrillation: Design and rationale of the BEAT PAROX-AF randomized clinical trial.
atrial fibrillation
catheter ablation
pulmonary vein isolation
pulsed field ablation
radiofrequency current
randomized trial
Journal
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
ISSN: 1532-2092
Titre abrégé: Europace
Pays: England
ID NLM: 100883649
Informations de publication
Date de publication:
22 Apr 2024
22 Apr 2024
Historique:
received:
20
02
2024
accepted:
16
04
2024
medline:
22
4
2024
pubmed:
22
4
2024
entrez:
22
4
2024
Statut:
aheadofprint
Résumé
Using thermal-based energy sources (radiofrequency energy (RF)/cryo energy) for catheter ablation is considered effective and safe when performing pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF). However, treatment success remains limited and complications can occur due to the propagation of thermal energy into nontarget tissues. We aim to compare pulsed field ablation (PFA) with RF ablation in terms of efficacy and safety for patients with drug-resistant paroxysmal AF. The BEAT PAROX-AF trial is a European multicenter, superiority, open-label randomized clinical trial in two parallel groups. A total of 292 participants were recruited in 9 high-volume European clinical centres in 5 countries. Patients with paroxysmal AF were randomized to PFA (FARAPULSE Endocardial Ablation System©, Boston Scientific) or RF using the CLOSE protocol with contact force sensing catheter (SmartTouch© catheter and CARTO© Biosense Webster). The primary endpoint will be the 1-year recurrence of atrial arrhythmia, and the major secondary safety endpoint will be the occurrence of acute (<7 days) procedure-related serious adverse events, or pulmonary vein stenosis, or atrio-oesophageal fistula up to 12-months. Additionally, five substudies investigate the effect of PFA on oesophageal safety, cerebral lesions, cardiac autonomic nervous system, durability of PVI as assessed during redo ablation procedures and atrial and ventricular function. The study began on December 27, 2021, and concluded recruitment on January 17, 2024. Results will be available in mid-2025. The BEAT PAROX-AF trial aims to provide critical insights into the optimal treatment approach for patients with paroxysmal AF. Clinicaltrials.gov, NCT05159492.
Sections du résumé
BACKGROUND AND AIMS
OBJECTIVE
Using thermal-based energy sources (radiofrequency energy (RF)/cryo energy) for catheter ablation is considered effective and safe when performing pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF). However, treatment success remains limited and complications can occur due to the propagation of thermal energy into nontarget tissues. We aim to compare pulsed field ablation (PFA) with RF ablation in terms of efficacy and safety for patients with drug-resistant paroxysmal AF.
METHODS
METHODS
The BEAT PAROX-AF trial is a European multicenter, superiority, open-label randomized clinical trial in two parallel groups. A total of 292 participants were recruited in 9 high-volume European clinical centres in 5 countries. Patients with paroxysmal AF were randomized to PFA (FARAPULSE Endocardial Ablation System©, Boston Scientific) or RF using the CLOSE protocol with contact force sensing catheter (SmartTouch© catheter and CARTO© Biosense Webster). The primary endpoint will be the 1-year recurrence of atrial arrhythmia, and the major secondary safety endpoint will be the occurrence of acute (<7 days) procedure-related serious adverse events, or pulmonary vein stenosis, or atrio-oesophageal fistula up to 12-months. Additionally, five substudies investigate the effect of PFA on oesophageal safety, cerebral lesions, cardiac autonomic nervous system, durability of PVI as assessed during redo ablation procedures and atrial and ventricular function. The study began on December 27, 2021, and concluded recruitment on January 17, 2024. Results will be available in mid-2025.
CONCLUSION
CONCLUSIONS
The BEAT PAROX-AF trial aims to provide critical insights into the optimal treatment approach for patients with paroxysmal AF.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov, NCT05159492.
Identifiants
pubmed: 38646926
pii: 7655711
doi: 10.1093/europace/euae103
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT05159492']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
John Allison
(J)
Besma Aouar
(B)
Tiziri Aoudjit
(T)
Julien Asselineau
(J)
Laura Benkert
(L)
Serge Boveda
(S)
Christian Enzinger
(C)
Hubert Cochet
(H)
Isabel Deisenhofer
(I)
Thomas Deneke
(T)
Eric Frison
(E)
Anne Gimbert
(A)
Pierre Jaïs
(P)
Josef Kautzner
(J)
Sebastien Knecht
(S)
Michelle Lycke
(M)
Philippe Maury
(P)
Rozenn Mingam
(R)
Petr Neuzil
(P)
Maider Piquet
(M)
Sophie Regueme
(S)
Stephanie Roseng
(S)
Marine Rousset
(M)
Daniel Scherr
(D)
Christopher Schneider
(C)
Christine Schwimmer
(C)
Maxime Sermesant
(M)
Cedrick Wallet
(C)
Dan Wichterle
(D)
Besma Aouar
(B)
Tiziri Aoudjit
(T)
Julien Asselineau
(J)
Eric Frison
(E)
Thomas Gil De Muro
(TG)
Anne Gimbert
(A)
Pierre Jaïs
(P)
Maria Merched
(M)
Laura Richert
(L)
Marine Rousset
(M)
Christine Schwimmer
(C)
Cédrick Wallet
(C)
Pierre Jais
(P)
Daniel Scherr
(D)
Sebastien Knecht
(S)
Petr Neuzil
(P)
Thomas Deneke
(T)
Anne Gimbert
(A)
Marine Rousset
(M)
Eric Frison
(E)
Julien Asselineau
(J)
Hubert Cochet
(H)
Dan Wichterle
(D)
Trudie Lobban
(T)
John Morgan
(J)
Besma Aouar
(B)
Thomas Gil De Muro
(TG)
Maxime Sermesant
(M)
Laura Richert
(L)
Christine Schwimmer
(C)
Cédrick Wallet
(C)
Andréa Alexander
(A)
Christiane Andriamandroso
(C)
Claire Duflos
(C)
Arnaud Denis
(A)
Benoît Guy-Moyat
(B)
Nicolas Derval
(N)
Frederic Sacher
(F)
Benjamin Bouyer
(B)
Ghassen Cheniti
(G)
Meleze Hocini
(M)
Pierre Jaïs
(P)
Philippe Maury
(P)
Anne Rollin
(A)
Serge Boveda
(S)
Stephane Combes
(S)
Jean-Paul Albenque
(JP)
Josef Kautzner
(J)
Jana Haskova
(J)
Petr Peichl
(P)
Predrag Stojadinovic
(P)
Dan Wichterle
(D)
Petr Neuzil
(P)
Pavel Hala
(P)
Jan Petru
(J)
Thomas Deneke
(T)
Elena Ene
(E)
Karin Nentwich
(K)
Isabel Deisenhofer
(I)
Felix Bourier
(F)
Florian Englert
(F)
Nico Erhard
(N)
Monika Hofmann
(M)
Marc Kottmaier
(M)
Sarah Lengauer
(S)
Tilko Reents
(T)
Jan Syvari
(J)
Marta Telishevska
(M)
Alex Tunsch Martinez
(AT)
Daniel Scherr
(D)
Martin Benedikt
(M)
Anna-Sophie Eberl
(AS)
Martin Manninger-Wuenscher
(M)
Ursula Rohrer
(U)
Sebastien Knecht
(S)
Mattias Duytschaever
(M)
Jean-Benoît Le Polain de Waroux
(JLP)
René Tavernier
(R)
Thomas Deneke
(T)
Daniel Scherr
(D)
Christian Enzinger
(C)
Dan Wichterle
(D)
Sébastien Knecht
(S)
Hubert Cochet
(H)
Maxime Sermesant
(M)
Vigneshwar Gurunathan
(V)
Julien Castelneau
(J)
Informations de copyright
© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.