The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
135
THERMOCOOL STSF catheter will be used in conjunction with TRUPULSE Generator to give PF ablation or RF ablation.
Royal Prince Alfred Hospital
Camperdown, Australia
Canberra Heart Rhythm
Garran, Australia
Westmead Hospital
Westmead, Australia
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Number of Participants with Primary Adverse Events (PAEs)
PAEs occurring within 7 days of an ablation which uses the BWI ablation system (including atrio-esophageal fistula and pulmonary vein stenosis occurring greater than 7 days of post ablation procedure) will be reported.
Time frame: Within one week (7 days) post-procedure
Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure
Rate of Freedom from documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT or AFL of unknown origin) within 91-365 days post index procedure will be reported. Freedom from atrial arrhythmia will be reported based on electrocardiographic data (greater than or equal to \[\>=30\] seconds on arrhythmia monitoring device) during the effectiveness evaluation period (Day 91-Day 365) off antiarrhythmic therapy.
Time frame: Within Day 91 to Day 365 post-procedure
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in AF symptoms.
Time frame: Baseline, Month 12
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University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada