Computational Cardiac Imaging Analysis to Guide Ventricular Tachycardia Ablation Procedures (AI-VT)

NCT06964152 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 171964
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical outcomes (clinical efficacy and safety) of using supplemental non-invasive computational ECG and cardiac imaging analysis tools to help guide ablation of ventricular tachycardia.

Conditions

Ventricular Tachycardia (VT); Premature Ventricular Contraction (PVC); Ventricular Fibrillation

Keywords

electrocardiography, arrhythmia mapping, 3D mapping, electroanatomic mapping, cardiac computed tomography, artificial intelligence, computational modeling

Outcome Measures

Primary Outcomes (2)

• Recurrent ventricular tachycardia

  Ventricular tachycardia episodes defined as implantable cardioverter defibrillator (ICD) therapies (anti-tachycardia pacing and shocks)

  1 year

• All-cause death

  1 year

Secondary Outcomes (5)

• Acute hemodynamic decompensation

  24 hours post-op

• Unplanned prolonged ICU upgrade

  48 hours

• acute cerebrovascular accident (embolic)

  24 hours post-op

• acute pericardial tamponade requiring intervention

  24 hours post-op

• vascular complication requiring intervention

  24 hours post-op

Study Arms (1)

VT ablation guided by supplemental non-invasive computational imaging analysis

EXPERIMENTAL

The electrophysiologist performing the standard-of-care VT ablation will have access to supplemental arrhythmia targeting/localization information provided by computational non-invasive ECG and/or cardiac CT imaging analysis

Diagnostic Test: Computational electrocardiography and cardiac computed tomography mapping

Interventions

Computational electrocardiography and cardiac computed tomography mapping DIAGNOSTIC_TEST

Use of non-invasive computational ECG and cardiac CT models to localize arrhythmia origins

VT ablation guided by supplemental non-invasive computational imaging analysis

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 21 and 100
• Evidence of ventricular tachycardia on ECG, telemetry or by CIED interrogation.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego Health

La Jolla, California, 92037, United States

Location

Related Publications (1)

• Krummen DE, Villongco CT, Ho G, Schricker AA, Field ME, Sung K, Kacena KA, Martinson MS, Hoffmayer KS, Hsu JC, Raissi F, Feld GK, McCulloch AD, Han FT. Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study. Circ Arrhythm Electrophysiol. 2022 Sep;15(9):e010857. doi: 10.1161/CIRCEP.122.010857. Epub 2022 Sep 7.

  PMID: 36069189 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Premature Complexes; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Cardiac Electrophysiology Physician

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2034
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1/1/2029-12/31/2032

Locations

US (1)