ClinicalTrials.gg
Enrolling by invitationNCT06964152AI-VTUpdated May 9, 2025

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

An interventional study of Computational electrocardiography and cardiac computed tomography mapping in Ventricular Tachycardia (VT), Premature Ventricular Contraction (PVC) and Ventricular Fibrillation, sponsored by University of California, San Diego. Enrolling by invitation at 1 site in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-09.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled May 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
21 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • electrocardiography, arrhythmia mapping, 3D mapping, electroanatomic mapping, cardiac computed tomography, artificial intelligence, computational modeling
03

In context

Tachycardia, Ventricular

451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.

This study's planned enrollment of 250 is above the median of 71 across 280 interventional studies indexed under Tachycardia, Ventricular.

Browse Tachycardia, Ventricular studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    VT ablation guided by supplemental non-invasive computational imaging analysis

    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

  • Diagnostic testComputational electrocardiography and cardiac computed tomography mapping

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

06

What researchers measure

Primary outcomes

  1. Recurrent ventricular tachycardia

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

    Time frame: 1 year

  2. All-cause death

    Time frame: 1 year

Secondary outcomes

  1. Acute hemodynamic decompensation

    acute development of hypotension, cardiogenic shock, escalation of inotropes/pressors, or need for unplanned percutaneous hemodynamic support

    Time frame: 24 hours post-op

  2. Unplanned prolonged ICU upgrade

    In outpatient elective cases, change in patient condiction neccessitating unplanned ICU upgrade lasting longer than 48 hours.

    Time frame: 48 hours

  3. acute cerebrovascular accident (embolic)

    Time frame: 24 hours post-op

  4. acute pericardial tamponade requiring intervention

    new expanding hemorrhagic pericardial effusion causing tamponade requiring urgent pericardiocentesis

    Time frame: 24 hours post-op

  5. vascular complication requiring intervention

    vascular access complication (bleeding or occlusion) requiring blood transfusion or vascular procedure (such as peripheral angioplasty)

    Time frame: 24 hours post-op

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 36069189 ↗

Individual participant data

Plan to share: Yes — Limited de-identified clinical datasets may be shared upon individual request

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: 1/1/2029-12/31/2032

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06964152
Responsible party
Gordon Ho (Principal Investigator, Cardiac Electrophysiology Physician, University of California, San Diego) — Principal investigator
First posted
May 9, 2025
Start date
May 1, 2024
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2034 (estimated)
Last update
May 9, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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