This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).
Documented symptomatic persistent atrial fibrillation (AF), which is defined as continuous AF that sustains beyond 7 days and less than 1 year and is documented by the following: Physician's note indicating continuous AF greater than or equal to (>=) 7 days but no more than 1 year; AND 1) Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrograms cannot >12 months prior to enrollment) OR 2) At least 24-hour Holter/ telemetry strip within 12 months prior to enrollment showing continuous AF
Failed at least one (1) antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable to the AAD
Age 18-80 years
Willing and capable of providing consent
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)
Documented severe dilatation of the left atrium (LA) (LAD >50 millimetre [mm]) antero-posterior diameter on imaging within 6 months prior to procedure
Documented severely compromised left ventricular ejection fraction (LVEF) (LVEF less than [<] 40 percent [%]) by imaging within 6 months prior to procedure
Severe mitral regurgitation or insufficiency, or the report claims: Regurgitant volume >=60 millilitre (mL)/beat, Regurgitant fraction >=50%, and/or effective regurgitant orifice area >=0.40 square centimetre (cm²).
Single group
Radiofrequency/Pulsed Field Ablation
DeviceRadiofrequency and pulsed field ablation by Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with the TRUPULSE™ generator will be used.
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter \[AF, AT or AFL\] of unknown origin) episodes based on electrocardiographic data and freedom from acute procedural failure, repeat ablation failure, non-study device failure, antiarrhythmic drug (AAD) failure, continuous AF/AT/AFL of unknown origin, and any direct current (DC) cardioversion procedure will be reported.
Occurrence of Early Onset Primary Adverse Event (PAE)
PAEs include the following Adverse Events (AEs): esophageal perforating complications (Atrio-esophageal fistula occuring up to 90 days post ablation procedure); phrenic nerve paralysis; cardiac Tamponade, perforation (occuring up to 30 days post ablation procedure); pulmonary vein stenosis (anytime during the 12 month follow up period); device or procedure related death (anytime during or after the ablation procedure); stroke/CVA; major vascular access complication/bleeding; thromboembolism; myocardial infarction; transient ischemic attack (TIA); pericarditis; heart block; pulmonary Edema (Respiratory Insufficiency); and vagal Nerve Injury/gastroparesis.
Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score at 12 Months Post Procedure
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 20 to 140. A score of 140 represents extreme distress (or extreme limitation, dissatisfaction or difficulty), while a score of 20 corresponds to no disability (or responding "not at all" limited, difficult or extreme satisfaction).
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