The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
149
Participants will undergo catheter ablation with the PF /RF ablation system consisting of the TRUPULSE Generator (delivers RF or PF energy through the study catheter) and the THERMOCOOL SMARTTOUCH SF (STSF) Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a Generator, for cardiac ablation).
Medical University Graz
Graz, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria
O L V Ziekenhuis
Aalst, Belgium
AZ Sint-Jan
Bruges, Belgium
Percentage of Participants With Primary Adverse Events (PAEs)
Percentage of participants with PAEs (within 7 days following the ablation procedure) was reported. PAEs included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (that occurred greater than 7 days and less than or equal to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Time frame: 90 days post-procedure on Day 1
Percentage of Participants With Acute Procedural Success
Percentage of participants with acute procedural success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure.
Time frame: Immediately post-procedure on Day 1
Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia
Percentage of participants with freedom from documented (symptomatic and asymptomatic) atrial arrhythmia episodes including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; unknown origin) episodes based on electrocardiographic data (greater than equal to \[\>=\]30 seconds on arrhythmia monitoring device) were reported. Participants with an AF/AT/AFL (of unknown origin) episode that is \>=30 seconds on arrhythmia monitoring device during the evaluation period were considered failures of this long-term effectiveness outcome measure. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the targeted pulmonary vein \[PVs\]) were also deemed a failure of this outcome measure. AFL of unknown origin was defined as all AFL except those cavotricuspid isthmus (CTI) dependent AFL as confirmed by 12-lead electrocardiogram (ECG) or entrainment maneuvers in an electrophysiology (EP) study.
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Ziekenhuis Oost-Limburg
Genk, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Aarhus University Hospital
Aarhus, Denmark
Gentofte Hospital
Hellerup, Denmark
Vilnius University Hospital Santaros Clinics
Vilnius, Lithuania
Time frame: Day 91 to Day 365