Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RF ablation | Experimental | Subjects undergoing RF ablation with the Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter for treatment of drug resistant symptomatic paroxysmal AF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF ablation | Device | RF ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of individual PAE versus total number of PAE | Incidence of individual PAE versus total number of PAE occured during study | 12 months |
| Incidence of entrance block after first encirclement (prior to 30-min waiting period) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Univ. Klinikum Graz | Graz | Austria | ||||
| OLV Aalst |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33952593 | Derived | Gupta D, Vijgen J, Potter T, Scherr D, Van Herendael H, Knecht S, Kobza R, Berte B, Sandgaard N, Albenque JP, Szeplaki G, Stevenhagen Y, Taghji P, Wright M, Duytschaever M. Quality of life and healthcare utilisation improvements after atrial fibrillation ablation. Heart. 2021 Aug;107(16):1296-1302. doi: 10.1136/heartjnl-2020-318676. Epub 2021 May 5. | |
| 32879974 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
% of subjects with ipsilateral PV isolation (entrance block) after first encirclement (evaluated prior to the 30 minute waiting period and adenosine challenge)
| 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) | from 3 up to 12 months |
| 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 |
| Mater Private Heart & Vascular Centre | Dublin | Ireland |
| Ospedaliera Universitaria Pisana | Pisa | Italy |
| Policlinico Caisilino Roma | Rome | Italy |
| Medisch Spectrum Twente | Enschede | Netherlands |
| Herzzentrum, Luzerner Kantonsspital | Lucerne | Switzerland |
| Liverpool Heart and Chest Hospital | Liverpool | United Kingdom |
| St. Thomas' Hospital | London | United Kingdom |
| Duytschaever M, Vijgen J, De Potter T, Scherr D, Van Herendael H, Knecht S, Kobza R, Berte B, Sandgaard N, Albenque JP, Szeplaki G, Stevenhagen YJ, Taghji P, Wright M, Macours N, Gupta D. Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial. Europace. 2020 Nov 1;22(11):1645-1652. doi: 10.1093/europace/euaa157. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |