BEAT AF is a randomized controlled trial aiming to assess the efficacy and the safety of pulsed field energy in persistent AF ablation
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 persistent AF. Catheter ablation of AF uses either radiofrequency (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 allow assessing preliminary evidence of efficacy and safety of pulsed field energy in persistent AF ablation. For this purpose, a randomized clinical trial will be conducted to provide large clinical data of PEF of 1-year recurrence for persistent AF. The BEAT AF consortium gathers 9 European renowned clinical centres (France, Czech Republic, Germany, Austria, Belgium) to contribute to decrease the huge burden of AF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
83
PVI and Linear lesion using PEF
PVI and Linear lesion using CFRF
Medical University of Graz
Graz, Austria
AZ Sint-Jan Brugge-Oostende
Bruges, Belgium
Homolka Hospital
Prague, Czechia
Institute for Clinical and Experimental Medicine
Prague, Czechia
proportion of subjects experiencing 1-year single-procedure clinical success
The Primary Efficacy Endpoint is the proportion of subjects experiencing 1-year single-procedure clinical success, defined as : 1. Successful index AF ablation 2. Absence of atrial arrhythmia recurrence on any type of recording (≥ 30 sec by TTM (event monitor), Holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), 3. Absence of use of class I or III AAD (except for non-atrial arrhythmia or APBs) 4. Absence of redo ablation (except for typical flutter), in the 12 months following the index ablation procedure (including a blanking period of 60 days following the index ablation procedure).
Time frame: 1 year
proportion of subjects with 1-year multiple-procedures success
proportion of subjects with 1-year multiple-procedures success defined as the following up to 12 months following the index ablation procedure: 1. Absence of atrial arrhythmia recurrence on any type of recording ((≥ 30 sec by TTM (event monitor), Holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), 2. Absence of use of class I or III AAD (except for non-atrial arrhythmia or APBs)
Time frame: 1 year
health-related quality of life:
Health-related quality of life will be evaluated using the SF-12 questionnaire. The SF-12 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). High score indicates better functioning
Time frame: 6 months, 1 year
AF-specific quality of life
Improvement in AF-specific quality of life will be assessed using QualiTy-of-life (AFEQT) questionnaire. Scores range from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered)
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CHU Bordeaux
Pessac, France
CHU Toulouse
Toulouse, France
Clinique Pasteur, Toulouse
Toulouse, France
Cardiovascular Center Bad Neustadt
Bad Neustadt an der Saale, Germany
Deutsches Herzzentrum München
Munich, Germany
Time frame: 6 months, 1 year
Death
Proportion of participants with death
Time frame: 7 days, 1 year
Stroke
Proportion of participants with
Time frame: 7 days, 1 year
Embolic events from arrhythmia,
Proportion of participants with embolic events from arrhythmia
Time frame: 1 year
Myocardial infarction
Proportion of participants with Myocardial infarction
Time frame: 7 days
Persistent diaphragmatic paralysis
Proportion of participants with Persistent diaphragmatic paralysis
Time frame: 7 days
Transient ischemic attack (TIA)
Proportion of participants with Transient ischemic attack (TIA)
Time frame: 7 days
Peripheral or organ thromboembolism
Proportion of participants with Peripheral or organ thromboembolism
Time frame: 7 days
Cardiac Tamponade / Perforation
Proportion of participants with Cardiac Tamponade / Perforation
Time frame: 7 days
Pericarditis
Proportion of participants with Pericarditis
Time frame: 7 days
Hospitalisation
Proportion of participants with Hospitalisation (initial or prolonged), excluding hospitalisation solely due to arrhythmia recurrence
Time frame: 7 days
Heart block
Proportion of participants with Heart block
Time frame: 7 days
Vascular access complications
Proportion of participants with Vascular access complications
Time frame: 7 days
Pulmonary vein stenosis (PVS)
Proportion of participants with Pulmonary vein stenosis (PVS)
Time frame: 1 year
Atrio-oesophageal fistula
Proportion of participants with Atrio-oesophageal fistula
Time frame: 1 year
Total ablation procedure duration
Index Ablation Procedure parameters: Total ablation procedure duration (in minutes), skin to skin
Time frame: Baseline
Left atrial (LA) dwell time during ablation procedure
Index Ablation Procedure parameters: Left atrial (LA) dwell time, defined as the time (in minutes) transpiring from catheter entry to exit from the LA
Time frame: Baseline
Total fluoroscopy time during ablation procedure
Index Ablation Procedure parameters: Total fluoroscopy time (in minutes), skin-to-skin
Time frame: Baseline
PV diameter
Change in mean PV diameter 2 months
Time frame: 2 months
Incidence of acute vagal response during PVI
Incidence of acute vagal response during PVI
Time frame: Baseline
mean heart rate variability
Change in mean heart rate
Time frame: 1 year
heart rate variability
Change in heart rate
Time frame: 1 year
acute complete PVI with PEF
Proportion of participants with acute complete PVI with PEF
Time frame: 1 year
acute complete linear lesion with PEF
Proportion of participants with acute complete linear lesion with PEF
Time frame: 1 year