The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is: Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients? Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
571
Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation.
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
RECRUITINGProportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure.
Occurrence of defined Composite Serious Adverse Events after the procedure through Day 60.
Time frame: After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60
The primary effectiveness endpoint (PEE) is the proportion of Treatment Subjects with Treatment Success through the Day 365 Assessment.
Acute Procedural Success defined as Pulmonary Vein (PV) Isolation and Chronic Success. Chronic Success is defined as freedom from the following after the Blanking Period (60 days): * Arrhythmia: Occurrence of any Detectable Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Re-ablation: Any re-ablation for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Cardioversion: Any electrical cardioversion for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Antiarrhythmic Drug (AAD) Use: dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new AAD.
Time frame: Day 0 through the Day 365 Assessment
Atrial Arrhythmia Burden Success Endpoint
Atrial Arrhythmia Burden Success is defined as the proportion of Treatment subjects with atrial arrhythmia burden less than or equal to 0.1% in the time period post-blanking period through 6 months, as measured by LUX-Dx.
Time frame: Post-blanking period (Day 60) through 6 months (Day 180)
Cavo-Tricuspid Isthmus (CTI) Ablation - Acute Procedural Endpoint
Defined as the proportion of Treatment Subjects who underwent a Cavo-Tricuspid Isthmus (CTI) ablation during the Index Procedure, regardless of the atrial fibrillation cohort, with absence of conduction through the cavo-tricuspid isthmus in both directions (bidirectional block), achieved with the FARAFLEX™ Mapping and PFA Catheter only, and confirmed prior to the end of the Index Ablation Procedure.
Time frame: Index Ablation Procedure
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