The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Pulsed Field Ablation System Plus-PersAF is a feasible and safe treatment for PersAF and associated AFL
PersAFOne III study is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 60 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
Neuron Medical
Brno, Czechia
Nemocnice Na Homolce
Prague, Czechia
Primary Safety Endpoint: Composite Safety Endpoint (CSE) Defined as the Incidence of the Following Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related, as Adjudicated by the CEDMC
Percentage of Intent to Treat subjects with one or more of the specified device or procedure related SAEs Endpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up. Early onset (within 30 days of an Index or Remap Procedure) * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications requiring intervention * Heart block Late onset (any time during follow-up through 12 months) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula
Time frame: 30Days-12 months
Primary Effectiveness Endpoint: Acute Procedural Success Acute Vein Success
Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Cardiac Ablation System Plus during the first ablation procedure (Index or Rescheduled Index Procedure)
Time frame: Index Procedure
The Primary Safety Endpoint Assessed at 7 Days
Percentage of Intent to Treat subjects with one or more of the specified device or procedure related SAEs Endpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up. Early onset (within 7 days of an Index or Remap Procedure) * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications requiring intervention * Heart block Late onset (any time during follow-up through 12 months) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula
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Time frame: 7-Days
The Percentage of Subjects With a Device- or Procedure-related SAE
Percentage of subjects with one or more device or procedure related SAEs.
Time frame: 12 Months
The Percentage of Subjects With Stroke or TIA
The percentage of occurrence of stroke or TIA observed in any subjects
Time frame: 12 Months
The Percentage of Subjects Requiring Cardioversions
The percentage of subjects where cardioversion (s) was performed within the 12-month post index
Time frame: 12 Months
The Percentage of Subjects Requiring an Arrhythmia-related (AF, AFL or AT) Hospitalization
The percentage of subjects that were hospitalized for arrhythmia-related (AF, AFL or AT) reasons
Time frame: 12 Months