The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).
The objective of this study is to obtain First-in-Human (FIH) experience with the FARAFLEX mapping and PFA catheter in the treatment of persistent Atrial Fibrillation (persAF) or Paroxysmal Atrial Fibrillation (PAF). Subjects with symptomatic Persistent Atrial Fibrillation or symptomatic Paroxysmal Atrial Fibrillation will be included in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Subjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation. Using the investigational Boston Scientific FARAFLEX Mapping and Pulse Field Ablation (PFA) System, ablation of the pulmonary veins will be performed; ablation of the left atrial posterior wall, mitral isthmus (MI), LA roof line and/or cavo-tricuspid isthmus (CTI) is at the discretion of the investigator.
Subjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation. Using either FARAFLEX™ Mapping and PFA System or a commercially available ablation system, ablation of the pulmonary veins will be performed; ablation of the left atrial posterior wall, mitral isthmus (MI), LA roof line and/or cavo-tricuspid isthmus (CTI) is at the discretion of the investigator, per the selected catheter's IFU and in accordance with the guidelines.
UZ Brussel Hospital
Brussels, Belgium
RECRUITINGKlinicki bolnicki centar Split
Split, Croatia
RECRUITINGNemocnice Na Homolce Hospital
Prague, Czechia
RECRUITINGDevice or procedure-related Composite Serious Adverse Events (CSAEs)
the incidence of device or procedure-related Composite Serious Adverse Events (CSAEs) following the Index Procedure will be evaluated. Safety analyses will be reported by AF type (Paroxysmal vs. Persistent) and treatment group (FARAFLEX vs. Commercial catheter).
Time frame: Ablation Procedure (Day 0) - Day 7; Day 0- Day 30; Day 0- Day 360
Acute Procedural Success
The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PV) and the posterior wall (PW) during the Index Procedure, as clinically assessed by entrance and/or exit block. Effectiveness analyses will be reported by AF type (Paroxysmal vs. Persistent) and treatment group (FARAFLEX vs. Commercial catheter).
Time frame: At the end of the ablation procedure
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Fondazione PTV - Policlinico Tor Vergata
Roma, Italy
RECRUITING