The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
The primary and secondary Safety, Feasibility, Effectiveness and Performance will be evaluated against pre-specified criteria as determined by the Sponsor and FDA. The criteria set in this study have been previously used to demonstrate Safety, Feasibility, Effectiveness and Performance in FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF). The analysis of the primary safety and performance objective will take place once all the subjects with a study FARAPULSE Pulsed field ablation procedure attempt have reached 12 months of follow-up post-pulsed field ablation procedure. The analyses of the primary effectiveness objective will take place once all the subjects with a study pulsed field ablation procedure attempt have reached 34 \~ 36 months of follow-up post-pulsed field ablation procedure. The analyses for the secondary objectives will take place once all subjects with a study pulsed field ablation procedure attempt have reached 34\~36 months of follow-up post-pulsed field ablation procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
A pulmonary vein isolation will be performed using catheter ablation
AZ Sint-Jan Brugee
Bruges, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Neuron Medical
Brno, Czechia
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD). Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure
Time frame: 12 Months
Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months
To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD)
Time frame: 12 Months
Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE
Freedom from a serious adverse event (SAE) which has not been categorized as a Pulsed Field Ablation procedure event.
Time frame: 12 Months
Additional Performance Analyses: Acute Procedural Success
Acute Procedural success is the demonstration of Acute Vein Success (measured by % subjects) was determined by Isolation of an ablated PVI using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure), as clinically assessed by entrance block demonstrated ≥ 20 minutes after the last PVI lesion is made with or without adenosine testing
Time frame: 1 day
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Nemocnice Na Homolce
Prague, Czechia
IKEM Cardiac Center
Prague, Czechia
Copenhagen(Gentofte) Hospital
Hellerup, Denmark
Heart- and Diabetescenter NRW
Bad Oeynhausen, Germany
CCB Frankfurt
Frankfurt, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Asklepios-Hamburg,Germany
Hamburg, Germany
...and 3 more locations