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

NCT ID: NCT05572047

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2026-06-30

Brief Summary

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

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Other Intervention Names

CSE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arga Medtech SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ante Anic, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Split

Giorgi Papiashvili

Role: PRINCIPAL_INVESTIGATOR

Israeli-Georgian Medical Research Clinic Helsicore

Locations

University Hospital of Split

Split, , Croatia

KBC Zagreb

Zagreb, , Croatia

Israeli-Georgian Medical Research Clinic Helthycore Ltd

Tbilisi, , Georgia

Countries

Croatia; Georgia

References

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.

Reference Type: DERIVED

PMID: 40294734 (View on PubMed)

Other Identifiers

CIP CSR 01-2022

Identifier Type: -

Identifier Source: org_study_id