The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial fibrillation (AF).
At least 18 years old, or older if required by local law.
Subjects with symptomatic atrial fibrillation who have documented Persistent Atrial Fibrillation (PersAD) or Paroxysmal Atrial Fibrillation (PAF) with at least one documented symptomatic AF episode lasting at least 24 hours.
Willing and capable of providing informed consent.
Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center.
Left atrial anteroposterior (LA) diameter ≥ 6.5 cm, or if LA diameter is not available, non-indexed LA volume >100 mL.
Current atrial myxoma.
Current left atrial thrombus.
Any PV abnormality, stenosis, or stenting. Common and middle PVs are admissible.
Parallel
FARAFLEX Mapping and Pulsed Field Ablation System
DeviceCatheter used for electrophysiological mapping of cardiac structures and the treatment of paroxysmal or persistent atrial fibrillation.
The Primary Effectiveness Endpoint (PEE) is the Proportion of Randomized Subjects in the Main Study Cohort achieving Treatment Success through the Day 365 Assessment.
The Primary Effectiveness Endpoint analysis will compare Treatment Success between the Treatment Arm and the Control Arm in randomized subjects in the Main Study Cohort.
The Secondary Safety Endpoint is the rate of protocol-defined device- or procedure-related Composite Serious Adverse Events (CSAE).
The secondary safety endpoint will be evaluated in Randomized Treatment Arm subjects and will not contribute to study success criteria.
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This trial is not recruiting at the moment. You can still explore other options:
