The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Early Onset of Primary Adverse Events
Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events
Time frame: Within 7 days
Confirmation of entrance block
Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification)
Time frame: Intraoperative
Confirmation of bi-directional block
Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions
Time frame: Intraoperative
Incidence of Serious Adverse Device Effects (SADEs)
Incidence of Serious Adverse Device Effects (SADEs) during follow-up
Time frame: 1 Year
Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure
Time frame: 3, 6 and 12 months post-procedure
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