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

NCT ID: NCT03062046

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-27
• Study Completion Date: 2019-03-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RF ablation

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

Group Type: EXPERIMENTAL

RF ablation

Intervention Type: DEVICE

RF ablation

Interventions

RF ablation

RF ablation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LKH Univ. Klinikum Graz

Graz, , Austria

OLV Aalst

Aalst, , Belgium

AZ Sint-Jan

Bruges, , Belgium

ZOL Genk

Genk, , Belgium

Jessa Ziekenhuis

Hasselt, , Belgium

Aarhus Universitetshospital Skejby

Aarhus, , Denmark

Gentofte Hospital

Gentofte Municipality, , Denmark

Odense University Hospital

Odense, , Denmark

Clinique Clairval Marseille

Marseille, , France

Clinique Pasteur

Toulouse, , France

Mater Private Heart & Vascular Centre

Dublin, , Ireland

Ospedaliera Universitaria Pisana

Pisa, , Italy

Policlinico Caisilino Roma

Rome, , Italy

Medisch Spectrum Twente

Enschede, , Netherlands

Herzzentrum, Luzerner Kantonsspital

Lucerne, , Switzerland

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

St. Thomas' Hospital

London, , United Kingdom

Countries

Austria; Belgium; Denmark; France; Ireland; Italy; Netherlands; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33952593 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32879974 (View on PubMed)

Other Identifiers

ABI-173

Identifier Type: -

Identifier Source: org_study_id