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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RF ablation
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LKH Univ. Klinikum Graz
  • OLV Aalst
  • AZ Sint-Jan
  • ZOL Genk
  • Jessa Ziekenhuis
  • Aarhus Universitetshospital Skejby
  • Gentofte Hospital
  • Odense University Hospital
  • Clinique Clairval Marseille
  • Clinique Pasteur
  • Mater Private Heart & Vascular Centre
  • Ospedaliera Universitaria Pisana
  • Policlinico Caisilino Roma
  • Medisch Spectrum Twente
  • Herzzentrum, Luzerner Kantonsspital
  • Liverpool Heart and Chest Hospital
  • St. Thomas' Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RF ablation

Arm Description

Subjects undergoing RF ablation with the Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter for treatment of drug resistant symptomatic paroxysmal AF

Outcomes

Primary Outcome Measures

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.
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
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)

Secondary Outcome Measures

Incidence of individual PAE versus total number of PAE
Incidence of individual PAE versus total number of PAE occured during study
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)
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)

Full Information

First Posted
February 15, 2017
Last Updated
May 28, 2019
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03062046
Brief Title
Evaluation of Ablation Index and VISITAG™ (ABI-173)
Acronym
VISTAX
Official Title
Evaluation of Ablation Index and VISITAG™ Use for Pulmonary Vein Isolation (PVI) in Patients With Paroxysmal Atrial Fibrillation (PAF)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RF ablation
Arm Type
Experimental
Arm Description
Subjects undergoing RF ablation with the Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter for treatment of drug resistant symptomatic paroxysmal AF
Intervention Type
Device
Intervention Name(s)
RF ablation
Intervention Description
RF ablation
Primary Outcome Measure Information:
Title
Incidence of primary adverse events
Description
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.
Time Frame
7 days
Title
confirmation of entrance block
Description
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
Time Frame
intraoperative
Title
long-term effectiveness
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of individual PAE versus total number of PAE
Description
Incidence of individual PAE versus total number of PAE occured during study
Time Frame
12 months
Title
Incidence of entrance block after first encirclement (prior to 30-min waiting period)
Description
% of subjects with ipsilateral PV isolation (entrance block) after first encirclement (evaluated prior to the 30 minute waiting period and adenosine challenge)
Time Frame
intraoperative
Title
Long-term effectiveness: freedom from documented symptomatic atrial arrhythmia
Description
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)
Time Frame
from 3 up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Facility Information:
Facility Name
LKH Univ. Klinikum Graz
City
Graz
Country
Austria
Facility Name
OLV Aalst
City
Aalst
Country
Belgium
Facility Name
AZ Sint-Jan
City
Brugge
Country
Belgium
Facility Name
ZOL Genk
City
Genk
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
Country
Belgium
Facility Name
Aarhus Universitetshospital Skejby
City
Aarhus
Country
Denmark
Facility Name
Gentofte Hospital
City
Gentofte
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
Clinique Clairval Marseille
City
Marseille
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
Mater Private Heart & Vascular Centre
City
Dublin
Country
Ireland
Facility Name
Ospedaliera Universitaria Pisana
City
Pisa
Country
Italy
Facility Name
Policlinico Caisilino Roma
City
Rome
Country
Italy
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
Herzzentrum, Luzerner Kantonsspital
City
Luzern
Country
Switzerland
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
33952593
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.
Results Reference
derived
PubMed Identifier
32879974
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.
Results Reference
derived

Learn more about this trial

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

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