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

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

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Non-randomized, multi-center
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coherent Sine-Burst Electroporation for AF<br>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<br>* Use of coherent sine-burst electroporation to ablate paroxysmal and persistent AF<br>* Other names: CSE;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Ablation, Coherent Sine-Burst, Electroporation, CSE