A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF).

Official Title
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A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Multi-electrode Circular IRE Catheter and Multi-Channel IRE Generator in Paroxysmal AF

Conditions
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Refractory Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Multi-Channel Irreversible Electroporation (IRE) Generator
* Device: Multi-Channel Circular IRE Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) (Physician's note indicating recurrent self-terminating atrial fibrillation [AF]). At least one electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or telemetry strip Failed at least one Class I or Class III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF, contraindicated or intolerable to both Class I and Class III AAD Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements Willing and capable of providing consent Exclusion Criteria: AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (Example, untreated documented obstructive sleep apnea and acute alcohol toxicity) Previous left atrium (LA) ablation or surgery Participants known to require ablation outside the pulmonary vein (PV) region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White) Previously diagnosed with persistent AF (greater than [>] 7 days in duration) Severe dilatation of the LA (documented LAD >50 millimeters [mm] antero-posterior diameter by transthoracic echocardiography (TTE) within 6 month prior to enrollment)

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irreversible Electroporation (IRE) System<br>Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation will be treated with the IRE system which includes multi-electrode circular IRE catheter and the multi-channel IRE generator. | Device: Multi-Channel Irreversible Electroporation (IRE) Generator<br>* The multi-channel IRE Generator is intended for use during cardiac Pulsed Field Ablation (PFA) therapy. This device is used in conjunction with a compatible ablation catheter to create a closed electrical circuit capable of delivering pulsed electrical field energy.<br>* Other names: D-1417-01-I;Device: Multi-Channel Circular IRE Catheter<br>* The multi-channel circular IRE Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and when used with an IRE Generator, for cardiac ablation.<br>* Other names: D-1412-01-SI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Long Term Effectiveness Without Antiarrhythmic Drug (AAD) Use | Long term effectiveness is defined as freedom more than or equal to (>=) 30 seconds from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), and atrial flutter (AFL) of unknown origin based on electrocardiographic data during the effectiveness evaluation period. | 91-365 days post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Acute Procedural Success | Acute Procedural Success defined as confirmation of entrance block in all clinically relevant targeted pulmonary vein (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter will be considered as acute procedural failure. | Up to 12 months | 
| Number of Participants with Acute Reconnection | Acute reconnection identified by adenosine/isoproterenol challenge. Among all clinically relevant targeted PVs and by subject. | Up to 12 months | 
| Number of Participants with Rate of PV | Rate of PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted PVs and by subject. | Up to 12 months | 
| Number of Participants with Rate of Repeated Ablation | Rate of repeated ablation within the 12 months follow-up period, including timing (blanking period or after blanking) and rate of PV reconnection. | Up to 12 months | 
| Number of Participants with Primary Adverse Events (PAEs) | An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure. | Within 7 days of ablation procedure | 
| Number of Participants with Serious Adverse Events (SAEs) Within 7 days, 8-30 Days and More Than 30 Days of Initial Ablation Procedure | An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure. | Within 7 days, 8-30 days and more than (>) 30 days of initial ablation procedure | 
| Number of Participants with AEs | An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure. | Up to 12 months | 
| Number of Participants with SAEs | An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure. | Up to 12 months |