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
237
THERMOCOOL STSF will be used in conjunction with TRUPULSE Generator to give pulsed field (PF) ablation or radiofrequency (RF) ablation.
TRUPULSE Generator will be used to deliver PF/RF ablation.
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: 7 days post-procedure
Percentage of Participants with Freedom from Documented (Symptomatic and Asymptomatic) Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes and Other Failure Modes
The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic AF, AT, or AFL will be reported.
Time frame: Up to 274 days
Change From Baseline in Quality-of-Life (QOL) Improvement
Quality of life will be assessed as measured by the total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire score. The score ranges from 0 to 100, with higher scores indicating better quality of life.
Time frame: From baseline to 12 months post ablation procedure
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