Evaluation of Ablation Index and VISITAG™ (ABI-173) (VISTAX)

Evaluation of Ablation Index and VISITAG™ Use for Pulmonary Vein Isolation (PVI) in Patients With Paroxysmal Atrial Fibrillation (PAF)

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 Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: RF ablation

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • LKH Univ. Klinikum Graz
• Belgium
  • Aalst, Belgium
    • OLV Aalst
  • Brugge, Belgium
    • AZ Sint-Jan
  • Genk, Belgium
    • ZOL GENK
  • Hasselt, Belgium
    • Jessa Ziekenhuis
• Denmark
  • Aarhus, Denmark
    • Aarhus Universitetshospital Skejby
  • Gentofte, Denmark
    • Gentofte Hospital
  • Odense, Denmark
    • Odense University Hospital
• France
  • Marseille, France
    • Clinique Clairval Marseille
  • Toulouse, France
    • Clinique Pasteur
• Ireland
  • Dublin, Ireland
    • Mater Private Heart & Vascular Centre
• Italy
  • Pisa, Italy
    • Ospedaliera Universitaria Pisana
  • Rome, Italy
    • Policlinico Caisilino Roma
• Netherlands
  • Enschede, Netherlands
    • Medisch Spectrum Twente
• Switzerland
  • Luzern, Switzerland
    • Herzzentrum, Luzerner Kantonsspital
• United Kingdom
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital
  • London, United Kingdom
    • St. Thomas' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RF ablation; Subjects undergoing RF ablation with the Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter for treatment of drug resistant symptomatic paroxysmal AF	Device: RF ablation; RF ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	% 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

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): March 27, 2019

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ABI-173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No