Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial (FACILE-VT)

July 23, 2026 updated by: Roderick Tung, University of Arizona

This is a multicenter, prospective, parallel, randomized controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to conventional voltage- based ablation. The study has two treatment arms: conventional voltage mapping and ablation (control arm). In the investigational arm, the ablation strategy is guided by ILAM to target deceleration zones, blinded to voltage mapping. In the control arm, ablation will be performed to extensively ablate all low voltage regions (<1.5mV) during sinus rhythm, right ventricular (RV) pacing, or left ventricular (LV) pacing, with discretionary use of pacemapping and activation mapping. In both arms, mapping with be performed with a multielectrode catheter (HD Grid) and ablation will be performed using an irrigated tip catheter (FlexAbility SE or Tactiflex catheters).

In the control armonly voltage mapping displays will be utilized (blinded to functional ILAM and fractionation). High density mapping with automated last deflection annotation (Ensite X) will be performed in all patients randomized to ILAM approach during either sinus rhythm or RV pacing.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner University Medical Center Phoenix
        • Contact:
        • Principal Investigator:
          • Peter Weiss, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Criteria

To participate in this clinical investigation, the subjects must meet all of the following inclusion criteria:

  1. Patient is ≥18 years of age.
  2. Able and willing to comply with all study requirements.
  3. At least one documented episode of sustained MMVT (>30 sec) by either EGM or ECG (including Holter, or loop recorder) in the 6 months prior to enrollment.
  4. Informed of the nature of the study, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical study site.
  5. Refractory (i.e., not effective, not tolerated, or not desired) to at least one anti-arrhythmic medication (including, but not limited to beta blocker, mexiletine, amiodarone or sotalol) for treatment of MMVT.

  6. Structural heart disease (ischemic or non-ischemic) with one of the following (a, b or c):

    1. Evidence of myocardial scar by echocardiography (segmental wall motion or wall thinning), CT (wall thinning) and/or MRI (presence of delayed enhancement /late gadolinium enhancement) . CT or MRI with scar is mandatory for inclusion of NICM., or
    2. Left ventricular ejection fraction (EF) <50% [documented within the last 6 months via transthoracic echocardiogram (TTE), MRI] with presence of scar, or
    3. Arrhythmogenic RV cardiomyopathy/dysplasia (per 2010 ARVC/D Task Force Criteria)

Exclusion Criteria

Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:

  1. Active infection (positive blood culture).
  2. Patient is pregnant or nursing.
  3. Cardiac surgery via sternotomy (CABG or valve repair/replacement) within 30 days prior to enrollment.
  4. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor).
  5. Currently receiving support via extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD).
  6. Left Ventriclar ejection fraction < 15%.
  7. Stroke within 30 days or presence of LV thrombus within 1 month prior to enrollment.
  8. Idiopathic VT or preprocedural imaging without scar (MRI or CT).
  9. Limited life expectancy of 1 year or less.
  10. Presence of mitral and aortic valves both mechanical.
  11. Ventricular tachycardia secondary to electrolyte imbalance or any other reversible or non-cardiac cause.
  12. Severe aortic stenosis or flail mitral valve with severed mitral regurgitation.
  13. Thrombocytopenia (defined as platelet count <50,000/μl ) or coagulopathy.
  14. Ventricular arrhythmias secondary to underlying channelopathies (LQTS, Brugada Syndrome).
  15. Enrolled in an investigational study evaluating another device or drug that would confound the results of this study.
  16. Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirement of 1 year, or impact the scientific integrity of the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Density Voltage Mapping
high-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (<1.5 mV)
Device: High Density Voltage Mapping
high-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (<1.5 mV).
Experimental: Isochronal Late Activation Mapping (ILAM)
an isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite X™) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE & Tactiflex catheters).
Device: Isochronal Late Activation Mapping (ILAM)
an isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite X™) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE & Tactiflex catheters)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inducibility for VT
Time Frame: after initial 25 minutes of ablation (minutes of radiofrequency)
Inducibility for VT after initial 25 minutes of ablation (minutes of radiofrequency)
after initial 25 minutes of ablation (minutes of radiofrequency)
Recurrent VT
Time Frame: 1 year post procedure
recurrent VT at 1 year
1 year post procedure
CV Hospitalization
Time Frame: 1 year post procedure
Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year
1 year post procedure
Mortality
Time Frame: 1 year post procedure
Mortality at 1 year
1 year post procedure
Procedure Related Safety
Time Frame: Duration of Hospitalization (up to 7 days)
hematoma requiring transfusion, cardiac perforation, stroke, hemorrhage, pericardial effusion
Duration of Hospitalization (up to 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual assessment of four endpoints comprising the primary endpoint.
Time Frame: 1 year post procedure
Individual assessment of four individual endpoints comprising the primary endpoint.
1 year post procedure
Total radiofrequency time delivered and procedural time.
Time Frame: Duration of Procedure
Duration of Procedure
Reduction in VT burden
Time Frame: 1 year post procedure
1 year post procedure
Quality of Life improvement
Time Frame: 1 year post procedure
The overall quality of life will be assessed using the SF-36 instrument, which includes 36 items rated on a 4-point Likert scale. In all nine subscales, lower scores indicate poorer outcomes in various areas, including physical functioning, social limitations due to physical or mental health issues, challenges related to work or daily activities, and feelings of nervousness, depression, fatigue, exhaustion, and pain.
1 year post procedure
Procedural complications
Time Frame: Duration of Hospitalization (up to 7 days)
tamponade, hematoma requiring transfusion, stroke, emergent surgery
Duration of Hospitalization (up to 7 days)
Length of stay in hospital from index procedure
Time Frame: Duration of Hospitalization (up to 7 days)
Duration of Hospitalization (up to 7 days)
Rate of Acute Kidney Injury
Time Frame: 1 day post procedure
Number of Participants with acute kidney injury, verified by creatinine checked the day after ablation.
1 day post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

Abbott

Investigators

  • Principal Investigator: Roderick Tung, MD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003834

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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