Functional Substrate-Only Guided VT Ablation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional Substrate-Only Mapping without VT Induction, Standard-of-Care Mapping/Imaging.
- Who it may be relevant to
- Registry conditions: Ventricular Tachycardia, Sudden Cardiac Death. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Functional Substrate-Only Mapping Technique to Guide Ablation of Arrhythmogenic Substrate Underlying Ventricular Tachycardia
Overview
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
Interventions
- Procedure Functional Substrate-Only Mapping without VT Induction
In this arm, invasive maps will be constructed by annotating the latest deflection and peak frequency during voltage mapping of stable intrinsic rhythm to localize areas of slow conduction. Annotated algorithms are cleared by the FDA. No VT will be purposefully induced in this experimental arm. - Procedure Standard-of-Care Mapping/Imaging
Conventional invasive scar (voltage) and electrical VT (entrainment, activation, pace) mapping will be used to guide VT ablation. Functional substrate mapping will not be used in this arm. VT will be induced using standard protocols.
Primary outcome measures
- Time to composite endpoint (VT recurrence, death, or acute hemodynamic decompensation) [Time frame: 6 months]
Secondary outcome measures (7)
- VT burden (ICD therapy including shocks and ATP, sustained VT episodes >30 seconds) [Time frame: 6 months]
- Total Mapping Time [Time frame: immediately at the end of the procedure]
- Total fluoroscopy time [Time frame: immediately at the end of the procedure]
- total procedural time [Time frame: immediately at the end of the procedure]
- Procedural adverse events or complications [Time frame: 1 month]
- Use of general anesthesia [Time frame: immediately at the end of the procedure]
- Acute heart failure readmission [Time frame: 1 month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA San Diego Healthcare System, San Diego, CA — San Diego
Identifiers
NCT: NCT06464315 · CARA-007-23F