Clinical trial NCT06464315: Functional Substrate-Only Guided VT Ablation
Official title: Functional Substrate-Only Mapping Technique to Guide Ablation of Arrhythmogenic Substrate Underlying Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia
Sudden Cardiac Death
Keywords: functional substrate mapping
conduction slowing
isochronal late activation mapping (ILAM)
peak frequency signal analysis
deceleration zones
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-06-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Ventricular tachycardia (VT) is a leading cause of death and suffering in the Veteran population. Currently, ablation procedures are performed to destroy the diseased tissue that causes this problem. This study will test to see if an experimental strategy of only targeting regions of slow conduction without the induction of VT can improve the efficacy and safety of VT ablation. Once this study is completed, the investigators will know whether this ablation strategy could help increase the efficacy, safety and efficiency of ablation therapy of fatal heart rhythms.

Detailed description: Ventricular tachycardia (VT) remains a leading cause of death and morbidity in the veteran population, but current ablation procedures to treat VT are limited by hemodynamic instability of induced VT during standard invasive activation mapping (up to 80% of induced VT), lengthy ablation procedures (\~8 hours), and difficulty in accurately localizing the critical origination sites of VT. The long-term goal is to simplify VT ablation using invasive functional substrate mapping techniques to improve the safety, efficacy, and efficiency of VT catheter ablation. The overall objectives in this application are to i) perform a randomized clinical trial to test whether performing simplified VT ablation guided only by invasive functional substrate mapping without VT induction improves the safety and efficiency of VT ablation while maintaining similar efficacy compared to standard ablation and ii) mechanistically correlate abnormal functional substrate with VT origination sites localized using gold standard invasive activation mapping. The central hypothesis is that ablation of slowly conducting tissue characterized by high frequency signals is sufficient to eliminate VT and improves clinical outcomes of VT ablation. The rationale is that recently developed sophisticated techniques to characterize functionally abnormal tissue can localize critical VT-sustaining substrate without needing to subjecting patients to mapping of hemodynamically unstable VT which is routinely done during standard of care ablation. The central hypothesis will be tested by pursuing one primary specific aim: Perform a randomized clinical trial to determine whether VT ablation guided only by invasive functional substrate mapping without VT induction decreases procedure time, fluoroscopy time, and procedural complications while maintaining similar efficacy compared to standard VT ablation controls. This study also includes 2 sub-aims to uncover VT mechanisms characterizing the distance of slowly conducting tissue to VT exit sites and provide a method to unmask critical arrhythmogenic substrate in non-ischemic cardiomyopathy patients in whom scar is not easily identified. The research proposed is innovative because it tests a novel strategy using new algorithms that can identify the critical tissue sustaining VT without requiring the induction of VT. The proposed research is significant because a functional substrate-guided only approach to VT ablation while still localizing the critical tissue causing VT is expected to increase the safety, efficacy, and efficiency of treating a fatal heart rhythm disorder

Eligibility criteria: Inclusion Criteria:

* Men and women \>18 years of age referred for clinically indicated VT ablation and experience monomorphic or polymorphic scar-based VT documented by telemetry, ICD interrogation, ECG or event monitoring.
* Scar-based VT is defined as VT in patients with structural heart disease (assessed with either abnormal nuclear perfusion imaging (\>5% defect), late gadolinium uptake on cardiac MRI, wall thinning \<10mm or calcified myocardium on cardiac CT, akinesis or hypokinesis on echocardiogram, presence of Q waves on ECG, history of myocardial infarct).
* Patients undergoing epicardial VT ablation and who undergo prophylactic percutaneous hemodynamic support devices will also be included.

Exclusion Criteria:

* Patients without structural heart disease will be excluded from the pri-mary analysis, but enrolled in a prospective registry
* Patients who are pregnant
* Presence of intracardiac thrombus
* active acute coronary ischemia with unrevascularized coronary artery disease (CAD \>70% stenosis)
* Active bacteremia
* Inaccessible ventricles due to dual mechanical valves
* Inability to tolerate and inability to tolerate anticoagulation during ablation and for at least 1 month after ablation

Primary outcomes:
measure: Time to composite endpoint (VT recurrence, death, or acute hemodynamic decompensation)
timeFrame: 6 months
Secondary outcomes:
measure: VT burden (ICD therapy including shocks and ATP, sustained VT episodes >30 seconds)
timeFrame: 6 months
measure: Total Mapping Time
timeFrame: immediately at the end of the procedure
measure: Total fluoroscopy time
timeFrame: immediately at the end of the procedure
measure: total procedural time
timeFrame: immediately at the end of the procedure
measure: Procedural adverse events or complications
timeFrame: 1 month
measure: Use of general anesthesia
timeFrame: immediately at the end of the procedure
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Gordon Ho, MD
role: PRINCIPAL_INVESTIGATOR
References: