Paroxysmal Atrial FibrillationVISTAXNCT03062046
Evaluation of Ablation Index and VISITAG™ (ABI-173)
A study testing RF ablation in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 17 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- RF ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 17 sitesin 9 countries
- Study dates
- 27 Jan 2017to 27 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
- Age 18 years or older
- Signed Patient Informed Consent Form (ICF)
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Who cannot join
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous LA ablation or surgery
- Anticipated to receive ablation outside the PV ostia and CTI region
- Previously diagnosed with persistent AF (> 7 days in duration)
- LA size >50 mm
- LA thrombus
Show all 24Show fewer
- LVEF < 40%
- Uncontrolled heart failure or NYHA Class III or IV
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- History of a documented thromboembolic event (including TIA) within the past 6 months
- Previous PCI/MI within the past 3 months
- Previous cardiac surgery (e.g. CABG) within the past 6 months
- Previous valvular cardiac surgical/percutaneous procedure (e.g. ventriculotomy, atriomy, valve repair or replacement, presence of a prosthetic valve)
- Unstable angina pectoris
- Awaiting cardiac transplantation, cardiac surgery or other major surgery within the next 12 months.
- 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
- Acute illness, active systemic infection or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
- Presence of a condition that precludes vascular access
- Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial
- Current enrollment in an investigational study evaluating another device or drug.
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
- Life expectancy less than 12 months
- Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use
Trial locations and contacts
17 sites in 9 countries.
17 sites in 9 countries
Belgium4 sites
OLV Aalst
Aalst
AZ Sint-Jan
Bruges
ZOL Genk
Genk
Jessa Ziekenhuis
Hasselt
Denmark3 sites
Aarhus Universitetshospital Skejby
Aarhus
Gentofte Hospital
Gentofte Municipality
Odense University Hospital
Odense
Italy2 sites
Ospedaliera Universitaria Pisana
Pisa
Policlinico Caisilino Roma
Rome
United Kingdom2 sites
Liverpool Heart and Chest Hospital
Liverpool
St. Thomas' Hospital
London
About this study
Official title: 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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- RF ablation
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF ablationDevice
RF ablation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: RF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 12 months
Secondary outcomes (3)
Incidence of individual PAE versus total number of PAE
Incidence of individual PAE versus total number of PAE occured during study
Measured: 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)
Measured: 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)
Measured: from 3 up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start27 Jan 2017
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062046
- Sponsor's protocol ID
- ABI-173
- Acronym
- VISTAX
- Status last verified
- Jun 2025
- First submitted
- 15 Feb 2017
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 33952593Duytschaever 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.
PubMed 32879974
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ablation Index and VISITAG™ Use for Pulmonary Vein Isolation (PVI) in Patients With Paroxysmal Atrial Fibrillation (PAF)
- ClinicalTrials.gov ID
- NCT03062046
- Acronym / sponsor ID
- VISTAX / ABI-173
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF ablation | Experimental | Device: RF ablationSubjects undergoing RF ablation with the Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter for treatment of drug resistant symptomatic paroxysmal AF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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
- Age 18 years or older
- Signed Patient Informed Consent Form (ICF)
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Key exclusion criteria (24 listed)
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous LA ablation or surgery
- Anticipated to receive ablation outside the PV ostia and CTI region
- Previously diagnosed with persistent AF (> 7 days in duration)
- LA size >50 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF ablationRF ablation | Device | RF ablation |
Primary outcome
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.
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
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)
3 secondary outcomes
Incidence of individual PAE versus total number of PAE
Time frame: 12 months
Incidence of entrance block after first encirclement (prior to 30-min waiting period)
Time frame: intraoperative
Long-term effectiveness: freedom from documented symptomatic atrial arrhythmia
Time frame: from 3 up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Derived from this study: PubMed 33952593Gupta 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.
- Derived from this study: PubMed 32879974Duytschaever 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF ablation in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 17 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Belgium, Denmark, France, Italy, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of primary adverse events (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03062046, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.