Summary

Eligibility
for people ages 18-90 (full criteria)
Location
at San Diego, California
Dates
study started
completion around
Principal Investigator
by Gordon Ho, MD
Headshot of Gordon Ho
Gordon Ho

Description

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 a new non-invasive targeting tool can help guide doctors during the procedure and improve the outcomes of the ablation procedure. Once this study is completed, the investigators will know whether this tool could help increase the efficacy, safety and accuracy of ablation therapy of fatal heart rhythms.

Official Title

Computational Cardiac Mapping Techniques to Guide Ablation of Arrhythmogenic Substrate Underlying Ventricular Tachycardia

Details

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 high VT recurrence rates up to 60%, lengthy invasive procedures, and invasive risks and difficulty in accurately localizing all the critical arrhythmogenic sites sustaining VT. The long-term goal is to harness the power of computational modeling to improve the efficacy, efficiency and safety of VT catheter ablation. The overall objective of this study is to perform a randomized clinical trial to see if the incorporation of computational ECG mapping guidance during VT ablation improves clinical outcomes of VT recurrence and ablation efficiency. The central hypothesis is that use of forward solution computational ECG mapping can improve clinical outcomes of VT ablation by localizing VT origins located in arrhythmogenic myocardial substrate that are critical in sustaining VT. The rationale is that novel non-invasive ECG mapping may be able to overcome the challenges of conventional invasive mapping techniques and improve the low success rates of VT ablation. The central hypothesis will be tested by pursuing one primary specific aim: Perform a randomized clinical trial to determine whether the use of computational ECG analysis during VT ablation can 1) reduce recurrent VT and 2) decrease intra-procedural mapping time, fluoroscopy time, and number of invasive access sites. This randomized clinical trial will test whether a VT ablation strategy incorporating computational mapping will improve efficiency and freedom from VT compared to standard-of-care ablation. The research proposed is innovative because it tests the ability of a novel computational analysis technique developed by the investigators' lab to guide ablation of critical arrhythmogenic tissue underlying VT. The proposed research is significant because it is expected to translate novel computational techniques and rigorously test its ability to improve the efficacy and efficiency of a complex ablation procedure to treat a fatal heart rhythm disorder.

Keywords

Ventricular Tachycardia, Sudden Cardiac Death, 12-Lead Electrocardiography, machine learning, Tachycardia, Death, Sudden, Cardiac, Death, Computerized ECG Mapping, Supplemental ECG Mapping Guidance

Eligibility

You can join if…

Open to people ages 18-90

  • Men and women >18 years of age referred for clinically indicated ventricular tachycardia (VT) ablation and experience monomorphic or polymorphic VT documented by telemetry, implantable cardioverter-defibrillator (ICD) interrogation, electrocardiogram (ECG) or event monitoring
  • Patients deemed to be high risk for acute hemodynamic decompensation (PAINESD score >15) and require prophylactic temporary mechanical support (intra-aortic balloon pump, Impella, TandemHeart, or veno-arterial extra-corporeal membrane oxygenation support (VA ECMO) will also be included
  • Patients undergoing epicardial VT ablation will also be included

You CAN'T join if...

  • Patients who are pregnant
  • Presence of intracardiac thrombus
  • active acute coronary syndrome with unrevascularized coronary artery disease (CAD)
  • 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

Location

  • VA San Diego Healthcare System, San Diego, CA
    San Diego California 92161-0002 United States

Lead Scientist at UCSD

  • Gordon Ho, MD
    Gordon Ho, MD, is a physician-scientist developing novel technologies to improve personalized therapy of heart rhythm disorders. As a board certified cardiac electrophysiologist, he takes care of patients with fast, slow and irregular heart rhythms by performing minimally-invasive procedures to treat atrial and ventricular arrhythmias.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT06464315
Study Type
Interventional
Participants
Expecting 36 study participants
Last Updated