Non-invasive Mapping-guided Ablation of VT — NoMo-VT  

Ventricular Tachycardia Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

• NCT number: NCT06464315
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Gordon Ho, MD
• Phone: (858) 642-3147
• Email: Gordon.Ho@va.gov
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Completion date: September 30, 2028