Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation (BURST-AF)

To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Detailed Description

A prospective, single-arm, multi-center, multi-national, non-randomized study designed to provide clinical data to support the use of the Arga Medtech System in the ablation of atrial fibrillation.

Patients with paroxysmal AF will be treated using the Arga Medtech System to achieve pulmonary vein isolation (PVI) (and cavo-tricuspid isthmus (CTI) ablation as appropriate if history of CTI flutter or inducible flutter during procedure)

Patients with persistent AF will be treated using the Arga Medtech System to achieve PVI and posterior wall (PW) ablation (CTI ablation as above).

Patients will be remapped at 90 days post the index procedure to confirm absence of PV reconnection and durability of any additional lesion sets performed. Re-ablation is permitted during the remapping procedure if indicated. Re-ablation resets the 90-day blanking period.

Additional follow-ups will be conducted at 7 days, 30 days, 180 days and 360 days post the index or re-ablation procedure.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia, 21 000
    • University Hospital of Split
  • Zagreb, Croatia, HR-10 000
    • KBC Zagreb
• Georgia
  • Tbilisi, Georgia, 0112
    • Israeli-Georgian Medical Research Clinic Helthycore Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Scheduled for ablation of paroxysmal or persistent AF
• Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the duration of the study
• Willing and able to give informed consent
• Failed at least one antiarrhythmic drug (AAD) (Class I to IV) as evidenced by recurrent symptomatic AF or intolerable or contraindicated to the AAD

Exclusion Criteria:

• Contraindication to AF ablation, TEE or anticoagulation
• Duration of continuous AF lasting longer than 12 months
• History of previous LA ablation or surgical treatment of AF/AT/AFL
• AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause

• Structural heart disease described as:

  • LVEF <30% based on TTE within 6 months of procedure
  • Left atrial size > 50mm based on TTE within 6 months of procedure (parasternal view)
• An implanted pacemaker or ICD
• Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG)
• Previous cardiac valvular surgical or percutaneous procedure or prosthetic valve
• Interatrial baffle, closure device, patch, ASD or PFO
• Presence of a left atrial appendage occlusion device
• CABG or PTCA procedure within the last 6 months
• Unstable angina or ongoing myocardial ischemia
• Myocardial infarction within the previous 6 months
• Hypertrophic cardiomyopathy defined as left ventricular septal wall thickness > 1.5cm
• History of blood clotting or bleeding disease
• Prior history within the previous 6 months of documented cerebral infarction, TIA or system embolism
• Pregnant or lactating (current or anticipated within study follow-up)
• Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcomes measurement for this study
• Any other condition, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Coherent Sine-Burst Electroporation for AF; Patients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation (plus cavo-tricuspid isthmus ablation as necessary) Patients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation and posterior wall ablation (and cavo-tricuspid isthmus ablation as necessary)

Device: Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System; Use of coherent sine-burst electroporation to ablate paroxysmal and persistent AF; Other Names: CSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious system and procedure-related events	Incidence of system-related and procedure-related serious adverse events (SAEs).	Within one week (7 days) post-procedure)
Procedural Success	Number of patients that achieve procedural success defined as isolation of the pulmonary veins at the index or re-mapping procedure.	Acute and/or up to 90 days post procedure
Chronic isolation of the pulmonary veins	Rate of patients and targeted pulmonary veins with documented electrical isolation of the pulmonary veins, assessed by entrance and exit block during a mapping procedure ~90-days post procedure.	90 to 180 days post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from documented atrial fibrillation (AF)	Proportion of patients free from documented AF > or = 30 seconds of AF during follow-up.	Up to 455 days post-index procedure
Freedom from documented atrial arrhythmias (AF, AT and AFL)	Freedom from documented atrial arrhythmias (AF, AT and AFL) > or = to 30 seconds during follow-up.	Up to 455 days post-index procedure
Freedom from documented symptomatic recurrence of atrial arrhythmias	Freedom from recurrence of documented atrial arrhythmias (AF, AT and AFL) > or = to 30 seconds during follow-up.	Up to 455 days post-index procedure

Collaborators and Investigators

• Sponsor: Arga Medtech SA
• Investigators: Principal Investigator: Ante Anic, MD, University Hospital of Split; Principal Investigator: Giorgi Papiashvili, Israeli-Georgian Medical Research Clinic Helsicore

Publications and helpful links

General Publications

• Anic A, Velagic V, Papiashvili G, Sikiric I, Lorenzo M, Prepolec I, Aranza I, Kapanadze N, Dagelic M, Breskovic T, Jurisic Z. Sine wave electroporation in patients with atrial fibrillation: Initial results of the BURST-AF study. Heart Rhythm. 2025 Aug;22(8):1946-1956. doi: 10.1016/j.hrthm.2025.04.042. Epub 2025 Apr 26.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Ablation; CSE; Electroporation; Coherent Sine-Burst
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: CIP CSR 01-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes