The purpose of this study is to assess the safety, acute and long term effectiveness, during standard RF ablation procedures while using Ablation Index and VISITAG™ software in combination with a Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter. Furthermore, the role of Ablation Index and VISITAG™ workflow in creating contiguous ablation lines is assessed. The study is a prospective, non-randomized, post-market clinical evaluation. Up to 330 patients will be included in this study. All patients who qualify based on the study specific requirements will be invited to participate. The total duration of the study is estimated to be about 24 months (12 months enrollment period and 12 months of follow up). The clinical investigation population include subjects undergoing RF ablation for treatment of drug resistant symptomatic paroxysmal AF. Prior to enrollment in the clinical investigation, all subjects must meet the inclusion/exclusion criteria and are suitable candidates for enrollment in a clinical investigation in the opinion of the investigator. Subjects must have failed at least one antiarrhythmic drug (AAD) (Type I or III, including β-blocker) as evidenced by recurrent or are intolerant of the AAD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
340
RF ablation
LKH Univ. Klinikum Graz
Graz, Austria
OLV Aalst
Aalst, Belgium
AZ Sint-Jan
Bruges, Belgium
ZOL Genk
Genk, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Aarhus Universitetshospital Skejby
Aarhus, Denmark
Gentofte Hospital
Gentofte Municipality, Denmark
Odense University Hospital
Odense, Denmark
Clinique Clairval Marseille
Marseille, France
Clinique Pasteur
Toulouse, France
...and 7 more locations
Incidence of primary adverse events
A Primary adverse event (PAE) is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of ablation index.
Time frame: 7 days
confirmation of entrance block
Presence/absence of acute reconnection will be evaluated through a 30 minute waiting period and adenosine challenge. PVs where acute reconnection is identified during the waiting period or following adenosine challenge will be considered ablation index false positives
Time frame: intraoperative
long-term effectiveness
Freedom from documented atrial arrhythmia (atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL)) episodes (episodes ≥ 30 sec on arrhythmia monitoring device) during the effectiveness evaluation period (day 91-365)
Time frame: 12 months
Incidence of individual PAE versus total number of PAE
Incidence of individual PAE versus total number of PAE occured during study
Time frame: 12 months
Incidence of entrance block after first encirclement (prior to 30-min waiting period)
% of subjects with ipsilateral PV isolation (entrance block) after first encirclement (evaluated prior to the 30 minute waiting period and adenosine challenge)
Time frame: intraoperative
Long-term effectiveness: freedom from documented symptomatic atrial arrhythmia
Freedom from documented symptomatic atrial arrhythmia (AF, AT and AFL) episodes (episodes ≥ 30 sec on arrhythmia monitoring device) during the effectiveness evaluation period (day 91-365)
Time frame: from 3 up to 12 months
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