Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF)

NCT05159492 | Completed DMC FDA Device

• 2 other identifiers: CHUBX 2021/032021-A01854-37
• Study Type: interventional
• Target: 292
• Locations: 5 countries
• Sites: 9

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Paroxysmal Atrial Fibrillation; Cardiac Arrhythmia; Pulmonary vein Isolation; Catheter Ablation; RF Ablation; Pulsed Field Energy

Outcome Measures

Primary Outcomes (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 (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).

  1 year

Secondary Outcomes (24)

• proportion of subjects with 1-year multiple-procedures success

  1 year

• health-related quality of life:

  6 months, 1 year

• AF-specific quality of life

  6 months, 1 year

• Death

  7 days, 1 year

• Stroke

  7 days, 1 year

Study Arms (2)

PEF Arm

EXPERIMENTAL

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

Pulmonary vein isolation using Contact Force RF

ACTIVE COMPARATOR

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

Interventions

PVI using PEF DEVICE

PVI using PEF

PEF Arm

PVI using CFRF DEVICE

PVI using CFRF

Pulmonary vein isolation using Contact Force RF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with drug-resistant symptomatic PAF meeting all the following criteria:
• Paroxysmal: AF that terminates spontaneously or with intervention within 7 days of onset.
• Frequency:
• 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.
• Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
• Patient who are willing and capable of:
• 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.
• 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.

You may not qualify if:

• \. AF that is any of the following:
• Persistent (both early and longstanding) by diagnosis or continuous duration \> 7 days
• Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes 2. Any of the following atrial conditions:
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• 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
• 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:
• 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:
• Body Mass Index (BMI) \> 40.0

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (9)

Medical University of Graz

Graz, Austria

Location

AZ Sint-Jan Brugge-Oostende

Bruges, Belgium

Location

Homolka Hospital

Prague, Czechia

Location

Institute for Clinical and Experimental Medicine

Prague, Czechia

Location

CHU Bordeaux

Pessac, France

Location

CHU Toulouse

Toulouse, France

Location

Clinique Pasteur, Toulouse

Toulouse, France

Location

Cardiovascular Center Bad Neustadt

Bad Neustadt an der Saale, Germany

Location

Deutsches Herzzentrum München

Munich, Germany

Location

Related Publications (1)

• Erhard N, Frison E, Asselineau J, Aouar B, Boveda S, Cochet H, Deisenhofer I, Deneke T, Gimbert A, Kautzner J, Knecht S, Maury P, Neuzil P, Rousset M, Scherr D, Schneider CW, Sermesant M, Wichterle D, Jais P; BEAT-AF Study group. 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. Europace. 2024 May 2;26(5):euae103. doi: 10.1093/europace/euae103.

  PMID: 38646926 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label randomised controlled trial, in two parallel groups with a 1:1 allocation ratio

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 16, 2021
• Study Start: December 27, 2021
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: May 14, 2026

Record last verified: 2025-02

Locations

CZ (2); AU (1); FR (3); BE (1); DE (2)