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Atrial FibrillationBEAT PERS-AFNCT05418725

Ground-Breaking Electroporation-based Intervention for PERSistent Atrial Fibrillation Treatment (BEAT PERS-AF)

A study testing PVI and Linear lesion using PEF and PVI and Linear lesion using CFRF in people with Atrial Fibrillation, run by University Hospital, Bordeaux at 9 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

BEAT AF is a randomized controlled trial aiming to assess the efficacy and the safety of pulsed field energy in persistent AF ablation Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
PVI and Linear lesion using PEF and PVI and Linear lesion using CFRF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
9 sitesin 5 countries
Study dates
4 Nov 2022to 28 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with drug-resistant symptomatic persistent AF meeting all the following criteria:
  • Persistent: continuous drug resistant AF that is sustained beyond 7 days (but less than 1 year).
  • Frequency: At least one (1) documented episode by a recording such as ECG, EM, Holter monitor or telemetry strip within 6 months of enrolment.
  • Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.
  • Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
  • Patient who are willing and capable of:
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  • Providing informed consent to undergo study procedures AND
  • Participating in all examinations and follow-up visits and tests associated with this clinical study.
  • Patient having a smart phone compatible with the Event Monitor device.
  • Highly effective contraception for women of childbearing potential.
  • Effective oral anticoagulation >3 weeks prior to planned ablation procedure
  • Patient affiliated to or beneficiary of national health security scheme for French participants.

Who cannot join

  • 1. AF that is any of the following:
  • Paroxysmal AF by diagnosis or that terminates spontaneously within 7 days of onset
  • Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes 2. Any of the following atrial conditions:
  • <!-- -->
  • Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE)
  • Any prior atrial endocardial or epicardial ablation procedure, other than right sided cavotricuspid isthmus ablation or for right sided SVT
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  • Any prior atrial surgery
  • Intra-atrial septal patch or interatrial shunt
  • Atrial myxoma
  • Current LA thrombus
  • LA appendage closure, device or occlusion, past or anticipated
  • Any PV abnormality, stenosis or stenting (common and middle PVs are admissible) 3. At any time, one (1) or more of the following cardiovascular procedures, implants or conditions:
  • 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:
  • 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 who are pregnant, lactating, 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:
  • Body Mass Index (BMI) > 40.0
  • Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
  • Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
  • Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
  • Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
  • Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
  • Active systemic infection
  • COVID-19 disease
  • Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date.
  • 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:
  • FARAPULSE or any of its affiliates or contractors
  • The Investigator, sub-Investigators, or their medical office or practice, or healthcare organizations at which study procedures may be performed.

Trial locations and contacts

9 sites in 5 countries.

9 sites in 5 countries

France3 sites

  • CHU Bordeaux

    Pessac

  • CHU Toulouse

    Toulouse

  • Clinique Pasteur, Toulouse

    Toulouse

Other trials in France

Czechia2 sites

  • Homolka Hospital

    Prague

  • Institute for Clinical and Experimental Medicine

    Prague

Other trials in Czechia

Germany2 sites

  • Cardiovascular Center Bad Neustadt

    Bad Neustadt an der Saale

  • Deutsches Herzzentrum München

    Munich

Other trials in Germany

Austria1 site

  • Medical University of Graz

    Graz

Other trials in Austria

Belgium1 site

  • AZ Sint-Jan Brugge-Oostende

    Bruges

Other trials in Belgium

About this study

BEAT AF is a randomized controlled trial aiming to assess the efficacy and the safety of pulsed field energy in persistent AF ablation

Read the detailed description

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.

Being tested
PVI and Linear lesion using PEF, PVI and Linear lesion using CFRF
Keywords
Persistent Atrial Fibrillation, Cardiac Arrhythmia, Pulmonary vein Isolation, Catheter Ablation, RF Ablation, Pulsed Field Energy, Linear lesion
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PVI and Linear lesion using PEFDevice

    PVI and Linear lesion using PEF

  • PVI and Linear lesion using CFRFDevice

    PVI and Linear lesion using CFRF

Study groups in NCT05418725
Study groupRoleWhat they receive
PEF ArmExperimentalPEF 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. Linear lesion will be delivered using 8 deliveries using 2000 V at the posterior left atrium
Receives: Device: PVI and Linear lesion using PEF
Pulmonary vein isolation and linear lesion using Contact Force RFActive comparatorThe 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). Linear lesion will be delivered at the posterior left atrium.
Receives: Device: PVI and Linear lesion using CFRF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 year

Secondary outcomes (26)

  1. 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)

    Measured: 1 year

  2. 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

    Measured: 6 months, 1 year

  3. 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)

    Measured: 6 months, 1 year

  4. Death

    Proportion of participants with death

    Measured: 7 days, 1 year

  5. Stroke

    Proportion of participants with

    Measured: 7 days, 1 year

  6. Embolic events from arrhythmia,

    Proportion of participants with embolic events from arrhythmia

    Measured: 1 year

  7. Myocardial infarction

    Proportion of participants with Myocardial infarction

    Measured: 7 days

  8. Persistent diaphragmatic paralysis

    Proportion of participants with Persistent diaphragmatic paralysis

    Measured: 7 days

  9. Transient ischemic attack (TIA)

    Proportion of participants with Transient ischemic attack (TIA)

    Measured: 7 days

  10. Peripheral or organ thromboembolism

    Proportion of participants with Peripheral or organ thromboembolism

    Measured: 7 days

  11. Cardiac Tamponade / Perforation

    Proportion of participants with Cardiac Tamponade / Perforation

    Measured: 7 days

  12. Pericarditis

    Proportion of participants with Pericarditis

    Measured: 7 days

  13. Hospitalisation

    Proportion of participants with Hospitalisation (initial or prolonged), excluding hospitalisation solely due to arrhythmia recurrence

    Measured: 7 days

  14. Heart block

    Proportion of participants with Heart block

    Measured: 7 days

  15. Vascular access complications

    Proportion of participants with Vascular access complications

    Measured: 7 days

  16. Pulmonary vein stenosis (PVS)

    Proportion of participants with Pulmonary vein stenosis (PVS)

    Measured: 1 year

  17. Atrio-oesophageal fistula

    Proportion of participants with Atrio-oesophageal fistula

    Measured: 1 year

  18. Total ablation procedure duration

    Index Ablation Procedure parameters: Total ablation procedure duration (in minutes), skin to skin

    Measured: Baseline

  19. 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

    Measured: Baseline

  20. Total fluoroscopy time during ablation procedure

    Index Ablation Procedure parameters: Total fluoroscopy time (in minutes), skin-to-skin

    Measured: Baseline

  21. PV diameter

    Change in mean PV diameter 2 months

    Measured: 2 months

  22. Incidence of acute vagal response during PVI

    Incidence of acute vagal response during PVI

    Measured: Baseline

  23. mean heart rate variability

    Change in mean heart rate

    Measured: 1 year

  24. heart rate variability

    Change in heart rate

    Measured: 1 year

  25. acute complete PVI with PEF

    Proportion of participants with acute complete PVI with PEF

    Measured: 1 year

  26. acute complete linear lesion with PEF

    Proportion of participants with acute complete linear lesion with PEF

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start4 Nov 2022
  3. Primary completion28 May 2025
  4. Study completion28 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label randomised non-comparative trial, in two parallel groups with a 2:1 allocation ratio
Masking
Single blind
Who is masked
Participant
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05418725
Sponsor's protocol ID
CHUBX 2021/62
Acronym
BEAT PERS-AF
Status last verified
Jun 2025
First submitted
9 Jun 2022
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing PVI and Linear lesion using PEF and PVI and Linear lesion using CFRF in people with Atrial Fibrillation, run by University Hospital, Bordeaux at 9 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France, Czechia, Germany, Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proportion of subjects experiencing 1-year single-procedure clinical success (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05418725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

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