An interventional study of PVI using PEF and PVI using CFRF in Atrial Fibrillation, sponsored by University Hospital, Bordeaux. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
BEAT AF is a randomized controlled trial aiming to demonstrate that pulsed field energy is faster, more effective and safer (tissue selectivity) than RF for paroxysmal 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 paroxysmal 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 demonstrate that PEF ablation is faster, more effective and safer (tissue selectivity) than RF ablation to treat paroxysmal AF. For this purpose, a randomized clinical trial will be conducted to provide first comparative evidence of the superiority of PEF over RF on the rate of 1-year recurrence for paroxysmal 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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 292 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with drug-resistant symptomatic PAF meeting all the following criteria:
i. Physician documentation of recurrent PAF (two or more episodes) within 6 months, AND ii. At least one (1) documented episode by a recording such as ECG, Event Monitor, Holter monitor or telemetry strip within 12 months of enrolment.
c. Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.
Patient who are willing and capable of:
Exclusion Criteria:
1. AF that is any of the following:
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a. Sustained ventricular tachycardia or any ventricular fibrillation b. Hemodynamically significant valvular disease: i. Valvular disease that is symptomatic ii. Valvular disease causing or exacerbating congestive heart failure iii. Aortic stenosis: if already characterized, valve area \< 1.5cm or gradient > 20 mm Hg iv. Mitral stenosis: if already characterized, valve area \< 1.5cm or gradient > 5 mm Hg v. Aortic or mitral regurgitation associated with abnormal LV function or hemodynamic measurements c. Hypertrophic cardiomyopathy d. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty e. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices f. Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access g. History of rheumatic fever h. History of congenital heart disease with any residual anatomic or conduction abnormality 4. Any of the following procedures, implants or conditions:
a. At baseline: i. New York Heart Association (NYHA) Class III/IV ii. Left ventricular ejection fraction (LVEF) \< 40% iii. Symptomatic hypotension iv. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP measurements at baseline assessment) v. Symptomatic resting bradycardia vi. Implantable loop recorder or insertable cardiac monitor, b. Within the 3 months preceding the Consent Date: i. Myocardial infarction ii. Unstable angina iii. Percutaneous coronary intervention iv. Heart failure hospitalization v. Pericarditis or symptomatic pericardial effusion vi. Gastrointestinal bleeding c. Within the 6 months preceding the Consent Date: i. Heart surgery ii. Stroke, TIA or intracranial bleeding iii. Any thromboembolic event iv. Carotid stenting or endarterectomy 5. Diagnosed disorder of blood clotting or bleeding diathesis 6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Contraindication to both CT and MRI 8. Sensitivity to contrast media not controllable by premedication 9. Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period 10. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:
i. Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus (HgbA1c > 8.0% if test result already obtained), untreated obstructive sleep apnea or active alcohol abuse j. Predicted life expectancy less than one (1) year 11. Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements/ Patient under legal protection 12. Current or anticipated enrollment in any other clinical study. 13. Employees / family members of:
PEF is a non-thermal ablation modality using extremely short high voltage pulses to induce cell death, with tissue selectivity, cardiomyocytes being much more sensitive to this energy than Phrenic nerve or Esophageal cells. Energy (2000 V) will be delivered 8 times per vein with 2 different catheter configurations and rotations
Device: PVI using PEF
The PVI strategy using RF is very standard. The CARTO© platform will be used, with a contact force catheter (SmartTouch), aiming at an ablation index value of 300 to 400 on the posterior wall, and at least 500 on the anterior wall. Power will be limited to 35/45 W, with a distance between consecutive deliveries of 6 mm or less (CLOSE protocol).
Device: PVI using CFRF
PVI using PEF
PVI using CFRF
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 (2017 HRS consensus statement): 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) 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)
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)
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
Change in mean heart rate
Time frame: 1 year
heart rate variability
Change in heart rate variability
Time frame: 1 year
Plan to share: Undecided
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux