Clinical trial NCT03062046: Evaluation of Ablation Index and VISITAG™ (ABI-173)
Official title: Evaluation of Ablation Index and VISITAG™ Use for Pulmonary Vein Isolation (PVI) in Patients With Paroxysmal Atrial Fibrillation (PAF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Symptomatic paroxysmal AF who had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), holter monitor or telemetry strip
2. Failed at least one antiarrhythmic drug (AAD) (Type I or III, including β-blocker) as evidenced by recurrent symptomatic AF, or intolerance to the AAD
3. Age 18 years or older
4. Signed Patient Informed Consent Form (ICF)
5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
2. Previous LA ablation or surgery
3. Anticipated to receive ablation outside the PV ostia and CTI region
4. Previously diagnosed with persistent AF (\> 7 days in duration)
5. LA size \>50 mm
6. LA thrombus
7. LVEF \< 40%
8. Uncontrolled heart failure or NYHA Class III or IV
9. History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
10. History of a documented thromboembolic event (including TIA) within the past 6 months
11. Previous PCI/MI within the past 3 months
12. Previous cardiac surgery (e.g. CABG) within the past 6 months
13. Previous valvular cardiac surgical/percutaneous procedure (e.g. ventriculotomy, atriomy, valve repair or replacement, presence of a prosthetic valve)
14. Unstable angina pectoris
15. Awaiting cardiac transplantation, cardiac surgery or other major surgery within the next 12 months.
16. Significant pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
17. Acute illness, active systemic infection or sepsis
18. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
19. Presence of a condition that precludes vascular access
20. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial
21. Current enrollment in an investigational study evaluating another device or drug.
22. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
23. Life expectancy less than 12 months
24. Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use

Primary outcomes:
measure: Incidence of primary adverse events
timeFrame: 7 days
measure: confirmation of entrance block
timeFrame: intraoperative
measure: long-term effectiveness
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of individual PAE versus total number of PAE
timeFrame: 12 months
measure: Incidence of entrance block after first encirclement (prior to 30-min waiting period)
timeFrame: intraoperative
measure: Long-term effectiveness: freedom from documented symptomatic atrial arrhythmia
timeFrame: from 3 up to 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Univ. Klinikum Graz
city: Aalst
country: Belgium
facility: OLV Aalst
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Genk
country: Belgium
facility: ZOL Genk
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital Skejby
city: Gentofte
country: Denmark
facility: Gentofte Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Marseille
country: France
facility: Clinique Clairval Marseille
city: Toulouse
country: France
facility: Clinique Pasteur
city: Dublin
country: Ireland
facility: Mater Private Heart & Vascular Centre
city: Pisa
country: Italy
facility: Ospedaliera Universitaria Pisana
city: Rome
country: Italy
facility: Policlinico Caisilino Roma
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Luzern
country: Switzerland
facility: Herzzentrum, Luzerner Kantonsspital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: St. Thomas' Hospital
Study officials:
References:
citation: 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.
citation: 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.