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

Paroxysmal Atrial Fibrillation Clinical Trial

— VISTAX  

Official title:

Evaluation of Ablation Index and VISITAG™ Use for Pulmonary Vein Isolation (PVI) in Patients With Paroxysmal Atrial Fibrillation (PAF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062046
• Other study ID #: ABI-173
• Status: Completed
• Phase: N/A
• Start date: January 27, 2017
• Est. completion date: March 27, 2019

Study information

• Verified date: May 2019
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: March 27, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• RF ablation
RF ablation

Locations

Country	Name	City	State
Austria	LKH Univ. Klinikum Graz	Graz
Belgium	OLV Aalst	Aalst
Belgium	AZ Sint-Jan	Brugge
Belgium	ZOL Genk	Genk
Belgium	Jessa Ziekenhuis	Hasselt
Denmark	Aarhus Universitetshospital Skejby	Aarhus
Denmark	Gentofte Hospital	Gentofte
Denmark	Odense University Hospital	Odense
France	Clinique Clairval Marseille	Marseille
France	Clinique Pasteur	Toulouse
Ireland	Mater Private Heart & Vascular Centre	Dublin
Italy	Ospedaliera Universitaria Pisana	Pisa
Italy	Policlinico Caisilino Roma	Rome
Netherlands	Medisch Spectrum Twente	Enschede
Switzerland	Herzzentrum, Luzerner Kantonsspital	Luzern
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	St. Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Incidence of individual PAE versus total number of PAE	Incidence of individual PAE versus total number of PAE occured during study	12 months
Secondary	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)	intraoperative
Secondary	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)	from 3 up to 12 months