NCT03062046: VISTAX

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

Completed NA Last updated 25 June 2025

What this trial tests

NA trial testing RF ablation in Paroxysmal Atrial Fibrillation in 340 participants. Completed in 27 March 2019.

Timeline

27 January 2017

Primary endpoint
27 March 2019

27 March 2019

Quick facts

Lead sponsor	Biosense Webster, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	340
Start date	27 January 2017
Primary completion	27 March 2019
Estimated completion	27 March 2019
Sites	17 locations across France, Denmark, Italy, Netherlands, Belgium, Austria, Ireland, United Kingdom

Drugs / interventions tested

• RF ablation

Conditions studied

• Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →

Sponsor

Biosense Webster, Inc. — full company profile →

Who can join

18 and older, any sex, with Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial.
   Duytschaever M, Vijgen J, De Potter T, Scherr D, et al · · 2020 · cited 85× · PMID 32879974 · DOI 10.1093/europace/euaa157
2. Quality of life and healthcare utilisation improvements after atrial fibrillation ablation.
   Gupta D, Vijgen J, Potter T, Scherr D, et al · · 2021 · cited 30× · PMID 33952593 · DOI 10.1136/heartjnl-2020-318676