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

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ClinicalTrials.gov Identifier: NCT03062046
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Tracking Information
First Submitted Date  ICMJE February 15, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE January 27, 2017
Actual Primary Completion Date March 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
  • Incidence of individual PAE versus total number of PAE [ Time Frame: 12 months ]
    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) [ Time Frame: intraoperative ]
    % 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 [ Time Frame: from 3 up to 12 months ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Ablation Index and VISITAG™ (ABI-173)
Official Title  ICMJE Evaluation of Ablation Index and VISITAG™ Use for Pulmonary Vein Isolation (PVI) in Patients With Paroxysmal Atrial Fibrillation (PAF)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation
Intervention  ICMJE Device: RF ablation
RF ablation
Study Arms  ICMJE Experimental: RF ablation
Subjects undergoing RF ablation with the Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter for treatment of drug resistant symptomatic paroxysmal AF
Intervention: Device: RF ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2019)
340
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2017)
330
Actual Study Completion Date  ICMJE March 27, 2019
Actual Primary Completion Date March 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   France,   Ireland,   Italy,   Netherlands,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03062046
Other Study ID Numbers  ICMJE ABI-173
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Biosense Webster, Inc.
Study Sponsor  ICMJE Biosense Webster, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biosense Webster, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP