NCT06931821 · University of Arizona
Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial
(FACILE-VT)
What this study is about
This is a conducted at multiple hospitals, forward-looking, parallel, randomly assigned controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to conventional voltage- based ablation. The study has two treatment treatment group$1: conventional voltage mapping and ablation (control treatment group$1).
View original scientific description
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.
Interventions
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)
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).
Primary outcome measures
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)
Recurrent VT
Time frame: 1 year post procedure
recurrent VT at 1 year
CV Hospitalization
Time frame: 1 year post procedure
Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year
Mortality
Time frame: 1 year post procedure
Mortality at 1 year
Procedure Related Safety
Time frame: Duration of Hospitalization (up to 7 days)
hematoma requiring transfusion, cardiac perforation, stroke, hemorrhage, pericardial effusion
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient is ≥18 years of age.
- Able and willing to comply with all study requirements.
- 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.
- 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.
- 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.
- Structural heart disease (ischemic or non-ischemic) with one of the following (a, b or c):
- 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
- Left ventricular ejection fraction (EF) \<50% \[documented within the last 6 months via transthoracic echocardiogram (TTE), MRI\] with presence of scar, or
- 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:
- Active infection (positive blood culture).
- Patient is pregnant or nursing.
- Cardiac surgery via sternotomy (CABG or valve repair/replacement) within 30 days prior to enrollment.
- Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor).
- Currently receiving support via extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD).
- Left Ventriclar ejection fraction \< 15%.
- Stroke within 30 days or presence of LV thrombus within 1 month prior to enrollment.
- Idiopathic VT or preprocedural imaging without scar (MRI or CT).
- Limited life expectancy of 1 year or less.
- Presence of mitral and aortic valves both mechanical.
- Ventricular tachycardia secondary to electrolyte imbalance or any other reversible or non-cardiac cause.
- Severe aortic stenosis or flail mitral valve with severed mitral regurgitation.
- Thrombocytopenia (defined as platelet count \<50,000/μl ) or coagulopathy.
- Ventricular arrhythmias secondary to underlying channelopathies (LQTS, Brugada Syndrome).
- Enrolled in an investigational study evaluating another device or drug that would confound the results of this study.
- 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.
Where
- Phoenix, Arizona
Collaborators
Abbott
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 27, 2026 · Source of record for eligibility and locations