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

NCT05572047 | Active Not Recruiting FDA Device

• 1 other identifier: CIP CSR 01-2022
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Ablation; Coherent Sine-Burst; Electroporation; CSE

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Freedom from documented atrial fibrillation (AF)

  Up to 455 days post-index procedure

• Freedom from documented atrial arrhythmias (AF, AT and AFL)

  Up to 455 days post-index procedure

• Freedom from documented symptomatic recurrence of atrial arrhythmias

  Up to 455 days post-index procedure

Study Arms (1)

Coherent Sine-Burst Electroporation for AF

EXPERIMENTAL

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

Interventions

Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System DEVICE

Use of coherent sine-burst electroporation to ablate paroxysmal and persistent AF

Also known as: CSE

Coherent Sine-Burst Electroporation for AF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arga Medtech SA: lead

Study Sites (3)

University Hospital of Split

Split, 21 000, Croatia

Location

KBC Zagreb

Zagreb, HR-10 000, Croatia

Location

Israeli-Georgian Medical Research Clinic Helthycore Ltd

Tbilisi, 0112, Georgia

Location

Related Publications (1)

• 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.

  PMID: 40294734 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Ante Anic, MD

  University Hospital of Split

  PRINCIPAL INVESTIGATOR

• Giorgi Papiashvili

  Israeli-Georgian Medical Research Clinic Helsicore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-randomized, multi-center

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: October 11, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (2); GE (1)