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

June 20, 2025 updated by: Biosense Webster, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of primary adverse events
Time Frame: 7 days
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
Time Frame: intraoperative
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
Time Frame: 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of individual PAE versus total number of PAE
Time Frame: 12 months
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)
Time Frame: intraoperative
% 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
Time Frame: from 3 up to 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosense Webster, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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