Advanced Imaging Technology for Ventricular Tachycardia

(AI-VT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

250 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Computational electrocardiography and cardiac computed tomography mapping for Ventricular Tachycardia?

Research shows that advanced imaging techniques, like body surface electrocardiographic mapping and cardiac computed tomography, can help identify the causes and locations of ventricular tachycardia (a dangerous heart rhythm problem). These imaging methods can guide treatment procedures, potentially improving outcomes by providing detailed information about the heart's structure and electrical activity. ^{1 2 3 4 5}

Is advanced imaging technology for ventricular tachycardia safe for humans?

The research articles focus on catheter ablation for ventricular tachycardia, which is a related treatment, and mention that there are relatively high rates of complications and adverse events. However, specific safety data for advanced imaging technology like computational electrocardiography or cardiac computed tomography mapping is not provided. ^{1 6 7 8 9}

How does the treatment of computational electrocardiography and cardiac computed tomography mapping for ventricular tachycardia differ from other treatments?

This treatment is unique because it uses advanced imaging techniques to noninvasively map the heart's electrical activity in real-time, providing detailed information about the origins and pathways of ventricular tachycardia. Unlike traditional methods that rely on invasive catheter mapping, this approach offers superior spatial resolution and can personalize treatment by identifying specific areas of the heart to target, potentially improving outcomes and reducing procedure time. ^{1 2 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 21 to 100 who have signs of ventricular tachycardia, which can be seen on an ECG, telemetry, or through a cardiac implantable electronic device (CIED). It's not specified who cannot join the trial.

Inclusion Criteria

Evidence of ventricular tachycardia on ECG, telemetry, or by CIED interrogation.

I am between 21 and 100 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo VT ablation guided by supplemental non-invasive computational imaging analysis

1 day

1 visit (in-person)

Immediate Post-op Monitoring

Participants are monitored for acute complications such as vascular issues and hemodynamic decompensation

48 hours

Follow-up

Participants are monitored for recurrent ventricular tachycardia and other long-term outcomes

1 year

Treatment Details

Interventions

• Computational electrocardiography and cardiac computed tomography mapping

Trial Overview The study tests if using advanced computer analysis of ECG and heart scans can improve the outcomes of procedures that aim to stop irregular heartbeats known as ventricular tachycardia.

Participant Groups

Group I: VT ablation guided by supplemental non-invasive computational imaging analysis Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

A total of 26,642 patients underwent catheter ablation procedures in Sweden from 2006 to 2015, with a median follow-up of 4.7 years, showing a shift towards more complex arrhythmias like atrial fibrillation (AF) and ventricular tachycardia (VT).

The study found that while the repeat ablation rate was highest for AF at 41% within 3 years, the overall rate of adverse events was low at 1.7%, indicating that catheter ablation is a relatively safe procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decade of catheter ablation of cardiac arrhythmias in Sweden: ablation practices and outcomes. Holmqvist, F., Kesek, M., Englund, A., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Inverse solution mapping of epicardial potentials: quantitative comparison with epicardial contact mapping. [2012]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Utility of cardiac imaging in patients with ventricular tachycardia. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Cardiac Imaging in Patients With Ventricular Tachycardia. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Field of view of mapping catheters quantified by electrogram associations with radius of myocardial attenuation on contrast-enhanced cardiac computed tomography. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Electrocardiographic imaging (ECGI), a novel diagnostic modality used for mapping of focal left ventricular tachycardia in a young athlete. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Trends and Outcomes of Catheter Ablation for Ventricular Tachycardia in a Community Cohort. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A decade of catheter ablation of cardiac arrhythmias in Sweden: ablation practices and outcomes. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

High-resolution structural-functional substrate-trigger characterization: Future roadmap for catheter ablation of ventricular tachycardia. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

[Comparative study of results of catheter ablation in ventricular tachycardia of different etiologies]. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Efficient Patient-Specific Simulations of Ventricular Tachycardia Based on Computed Tomography-Defined Wall Thickness Heterogeneity. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Noninvasive electroanatomic mapping of human ventricular arrhythmias with electrocardiographic imaging. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Personalized virtual-heart technology for guiding the ablation of infarct-related ventricular tachycardia. [2023]