Isochronal Late Activation Mapping for Ventricular Tachycardia

(FACILE-VT Trial)

Overseen By Priyanka Sharma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must be taking: Anti-arrhythmics

Disqualifiers: Active infection, Pregnancy, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating ventricular tachycardia (VT), a condition where the heart beats too fast, using Isochronal Late Activation Mapping (ILAM). The researchers aim to determine if ILAM, which targets specific heart areas, is as effective as the traditional method that treats larger low-energy areas. Participants will be divided into two groups: one using the new ILAM method and the other using the standard approach. Suitable candidates have experienced sustained VT episodes and have not responded well to at least one medication. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to more effective VT treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should be refractory (not responding well) to at least one anti-arrhythmic medication, which suggests that you may continue your current medications if they are not effective.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Isochronal Late Activation Mapping (ILAM) is being explored to treat ventricular tachycardia (VT), a fast and irregular heartbeat. In these studies, ILAM uses advanced technology to pinpoint areas in the heart that may need treatment, aiming to make the procedure safer and more effective.

Regarding safety, ILAM mapping is generally well-tolerated. Research indicates that targeting specific heart areas with ILAM has not led to unexpected or severe side effects. Patients who received ILAM-guided treatment did not experience more complications than those using other mapping methods.

Although specific phase data for this trial is unavailable, the use of ILAM in research offers some reassurance about its safety. While all procedures carry some risk, ILAM appears to be a safe option for people with VT. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these mapping techniques for ventricular tachycardia because they offer more precise ways to target areas in the heart that need treatment. Unlike standard mapping methods, which often display broader areas for ablation, High Density Voltage Mapping uses detailed data to hone in on sections with low voltage for more extensive and focused treatment. Isochronal Late Activation Mapping (ILAM) takes it a step further by identifying specific regions of crowding around conduction blocks, enabling targeted ablation with greater accuracy. This precision could lead to better outcomes and fewer complications for patients.

What evidence suggests that this trial's treatments could be effective for ventricular tachycardia?

This trial will compare two mapping techniques for treating ventricular tachycardia (VT): Isochronal Late Activation Mapping (ILAM) and High Density Voltage Mapping. Research has shown that ILAM might aid in treating VT by identifying the exact areas in the heart where abnormal electrical signals occur, allowing doctors to target these spots during treatment. This method uses detailed heart maps to enhance the accuracy of the ablation procedure, which removes or destroys the problematic tissue. One study indicated that ILAM can lead to successful treatment outcomes for VT patients. While more research is needed, these findings suggest that ILAM could offer more precise and effective treatments for VT. Meanwhile, High Density Voltage Mapping will display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area. ^{1 4 5 6 7}

Who Is on the Research Team?

Roderick Tung, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for individuals with ventricular tachycardia, a type of fast heart rhythm. Participants should have VT that's suitable for ablation treatment. Specific details about who can join or reasons why someone might not be eligible are not provided here.

Inclusion Criteria

Able and willing to comply with all study requirements

At least one documented episode of sustained MMVT (>30 sec) by either EGM or ECG 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

Exclusion Criteria

Limited life expectancy of 1 year or less

Patient is pregnant or nursing

Currently receiving support via extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo VT ablation using either ILAM-guided or conventional voltage-based mapping techniques

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for mortality, CV hospitalization, and quality of life

1 year

What Are the Treatments Tested in This Trial?

Interventions

• High Density Voltage Mapping
• Isochronal Late Activation Mapping (ILAM)

Trial Overview The study compares two methods to guide VT ablation: the new Isochronal Late Activation Mapping (ILAM) versus conventional voltage-based mapping. Patients will be randomly assigned to one of these strategies to see if ILAM is at least as good as the standard approach.

How Is the Trial Designed?

Group I: Isochronal Late Activation Mapping (ILAM) Experimental Treatment 1 Intervention

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).

Group II: High Density Voltage Mapping Active Control 1 Intervention

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)

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)00196-1/fulltext

Evaluation of noninvasive isochronal late activation ... Forty-seven patients (27.7% ischemic, 72.3% nonischemic) were studied; epicardial data was acquired in 30 (63.8%). No significant difference in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4695215/

A Systematic Analysis of Isochronal Late Activation Mapping Late potentials identified in the latest isochrone of activation during sinus rhythm are infrequently correlated with successful ablation sites for VT.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.042423

Targeted Ablation of Ventricular Tachycardia Guided by ... Isochronal late activation maps annotated to the latest local electrogram deflection were created with high-density multielectrode mapping ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1547527125001961

Evaluation of noninvasive isochronal late activation ... Forty-seven patients (27.7% ischemic, 72.3% nonischemic) were studied; epicardial data was acquired in 30 (63.8%).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06931821

NCT06931821 | Functional ElectroAnatomiC Isochronal ... This is a multicenter, prospective, parallel, randomized controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(23)00773-7/pdf

MP-453092-5 ISOCHRONAL LATE ACTIVATION ... Objective: The study aimed to evaluate the long-term outcome of rTOF patients who underwent EAM and ablation for primary and secondary prevention of MVT.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666501824003738

Clinical outcomes after ventricular tachycardia ablation ... A strategy of avoiding VT induction vs attempting VT induction resulted in a similar incidence of VT recurrence, heart transplant, or death at 1 year.