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

NCT03062046 | Completed

• 1 other identifier: ABI-173
• Study Type: interventional
• Target: 340
• Locations: 9 countries
• Sites: 17

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Incidence of individual PAE versus total number of PAE

  12 months

• Incidence of entrance block after first encirclement (prior to 30-min waiting period)

  intraoperative

• Long-term effectiveness: freedom from documented symptomatic atrial arrhythmia

  from 3 up to 12 months

Study Arms (1)

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

Device: RF ablation

Interventions

RF ablation DEVICE

RF ablation

RF ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (17)

LKH Univ. Klinikum Graz

Graz, Austria

Location

OLV Aalst

Aalst, Belgium

Location

AZ Sint-Jan

Bruges, Belgium

Location

ZOL Genk

Genk, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

Aarhus Universitetshospital Skejby

Aarhus, Denmark

Location

Gentofte Hospital

Gentofte Municipality, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Clinique Clairval Marseille

Marseille, France

Location

Clinique Pasteur

Toulouse, France

Location

Mater Private Heart & Vascular Centre

Dublin, Ireland

Location

Ospedaliera Universitaria Pisana

Pisa, Italy

Location

Policlinico Caisilino Roma

Rome, Italy

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Herzzentrum, Luzerner Kantonsspital

Lucerne, Switzerland

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

St. Thomas' Hospital

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33952593 DERIVED

• 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.

  PMID: 32879974 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: January 27, 2017
• Primary Completion: March 27, 2019
• Study Completion: March 27, 2019
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); DK (3); IT (2); CH (1); NL (1); BE (4); IE (1); FR (2); GB (2)