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

360 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment High Density Voltage Mapping, Isochronal Late Activation Mapping (ILAM) for Ventricular Tachycardia?

Research suggests that isochronal late activation mapping (ILAM) can effectively identify areas of slow heart conduction, which are often linked to successful treatment sites for ventricular tachycardia. This method helps visualize critical areas for treatment, potentially improving the success of procedures aimed at stabilizing heart rhythms. ^{1 2 3 4 5}

Is Isochronal Late Activation Mapping (ILAM) safe for humans?

The research does not provide specific safety data for Isochronal Late Activation Mapping (ILAM) in humans, but it is used in clinical settings for mapping heart rhythms, suggesting it is generally considered safe for such procedures. ^{1 2 3 6 7}

How does Isochronal Late Activation Mapping (ILAM) differ from other treatments for ventricular tachycardia?

Isochronal Late Activation Mapping (ILAM) is unique because it focuses on identifying areas of slow electrical conduction in the heart, which are critical for successful ablation of ventricular tachycardia. This method uses high-density mapping to visualize these slow conduction zones, which are often linked to effective treatment sites, offering a more targeted approach compared to traditional voltage-based mapping techniques. ^{1 2 3 8 9}

What is the purpose of this trial?

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.

Research Team

Roderick Tung, MD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of combined substrate-based mapping techniques to identify critical sites for ventricular tachycardia ablation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Automated isochronal late activation mapping to identify deceleration zones: Rationale and methodology of a practical electroanatomic mapping approach for ventricular tachycardia ablation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Isochronal difference mapping: an approach for mapping dynamic changes during reentrant ventricular tachycardia. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Comparative psychometric analysis of vector and isochrone cardiac activation maps. [2019]

5. China pubmed.ncbi.nlm.nih.gov

[Value of identifying the slow conduction zone of idiopathic left ventricular tachycardia by electroanatomic mapping]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

High-density substrate-guided ventricular tachycardia ablation: role of activation mapping in an attempt to improve procedural effectiveness. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Atrial Late Activation Mapping Predicts the Critical Isthmus of Left Atrial Re-entrant Tachycardia. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Reconstruction of endocardial potentials and activation sequences from intracavitary probe measurements. Localization of pacing sites and effects of myocardial structure. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Novel Mapping Strategies for Ventricular Tachycardia Ablation. [2020]