Ventricular Tachycardia (VT)AI-VTNCT06964152
Computational Cardiac Imaging Analysis to Guide Ventricular Tachycardia Ablation Procedures (AI-VT)
A study testing Computational electrocardiography and cardiac computed tomography mapping in people with Ventricular Tachycardia (VT) and Premature Ventricular Contraction (PVC), run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Ventricular Tachycardia (VT), Premature Ventricular Contraction (PVC), Ventricular Fibrillation
- What is being tested?
- Computational electrocardiography and cardiac computed tomography mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 31 Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 100
- Evidence of ventricular tachycardia on ECG, telemetry or by CIED interrogation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Use of Computational Cardiac Imaging Analysis to Guide Ventricular Tachycardia Ablation Procedures (AI-VT)
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
- Being tested
- Computational electrocardiography and cardiac computed tomography mapping
- Keywords
- electrocardiography, arrhythmia mapping, 3D mapping, electroanatomic mapping, cardiac computed tomography, artificial intelligence, computational modeling
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Premature Complexes, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computational electrocardiography and cardiac computed tomography mappingDiagnostic test
Use of non-invasive computational ECG and cardiac CT models to localize arrhythmia origins
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Computational electrocardiography and cardiac computed tomography mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent ventricular tachycardia
Ventricular tachycardia episodes defined as implantable cardioverter defibrillator (ICD) therapies (anti-tachycardia pacing and shocks)
Measured: 1 year
All-cause death
Measured: 1 year
Secondary outcomes (5)
Acute hemodynamic decompensation
acute development of hypotension, cardiogenic shock, escalation of inotropes/pressors, or need for unplanned percutaneous hemodynamic support
Measured: 24 hours post-op
Unplanned prolonged ICU upgrade
In outpatient elective cases, change in patient condiction neccessitating unplanned ICU upgrade lasting longer than 48 hours.
Measured: 48 hours
acute cerebrovascular accident (embolic)
Measured: 24 hours post-op
acute pericardial tamponade requiring intervention
new expanding hemorrhagic pericardial effusion causing tamponade requiring urgent pericardiocentesis
Measured: 24 hours post-op
vascular complication requiring intervention
vascular access complication (bleeding or occlusion) requiring blood transfusion or vascular procedure (such as peripheral angioplasty)
Measured: 24 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 May 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gordon Ho, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964152
- Sponsor's protocol ID
- 171964
- Acronym
- AI-VT
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Limited de-identified clinical datasets may be shared upon individual request
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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Use of Computational Cardiac Imaging Analysis to Guide Ventricular Tachycardia Ablation Procedures (AI-VT)
- ClinicalTrials.gov ID
- NCT06964152
- Acronym / sponsor ID
- AI-VT / 171964
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VT ablation guided by supplemental non-invasive computational imaging analysis | Experimental | Diagnostic Test: Computational electrocardiography and cardiac computed tomography mappingThe 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 |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 21 and 100
- Evidence of ventricular tachycardia on ECG, telemetry or by CIED interrogation.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computational electrocardiography and cardiac computed tomography mappingUse of non-invasive computational ECG and cardiac CT models to localize arrhythmia origins | Diagnostic test | VT ablation guided by supplemental non-invasive computational imaging analysis |
Primary outcome
Recurrent ventricular tachycardia
Time frame: 1 year
Ventricular tachycardia episodes defined as implantable cardioverter defibrillator (ICD) therapies (anti-tachycardia pacing and shocks)
All-cause death
Time frame: 1 year
5 secondary outcomes
Acute hemodynamic decompensation
Time frame: 24 hours post-op
Unplanned prolonged ICU upgrade
Time frame: 48 hours
acute cerebrovascular accident (embolic)
Time frame: 24 hours post-op
acute pericardial tamponade requiring intervention
Time frame: 24 hours post-op
vascular complication requiring intervention
Time frame: 24 hours post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 36069189Krummen 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.
- Individual participant dataSharing planned: Yes. Limited de-identified clinical datasets may be shared upon individual request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computational electrocardiography and cardiac computed tomography mapping in people with Ventricular Tachycardia (VT) and Premature Ventricular Contraction (PVC), run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent ventricular tachycardia (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06964152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.