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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of using advanced imaging tools to guide treatment for ventricular tachycardia, a heart rhythm problem. The focus is on non-invasive technology, such as special ECG (computational electrocardiography) and CT scans (cardiac computed tomography mapping), to provide detailed information during ablation, a procedure targeting problem areas in the heart. Individuals diagnosed with ventricular tachycardia and showing signs on heart monitoring tests may be suitable candidates for this study. As an unphased trial, it offers patients the opportunity to contribute to innovative research that could enhance future treatment strategies.

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 prior data suggests that this imaging technology is safe for guiding ventricular tachycardia ablation?

In a previous study, researchers found that advanced imaging tools like computational electrocardiography and cardiac computed tomography (CT) mapping can help treat ventricular tachycardia, a type of fast heart rhythm. These tools are non-invasive, requiring no surgery or entry into the body.

Research has shown that these imaging tools are generally well-tolerated. They produce detailed heart images, enabling doctors to pinpoint problem areas more accurately during procedures. Other studies have demonstrated the safety of using similar imaging for heart rhythm treatments.

No major reports of harmful effects have directly resulted from these imaging techniques. However, as with any medical procedure, discussing potential risks with a doctor is important. Overall, evidence suggests these tools are a safe option for guiding heart treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of advanced imaging technology for ventricular tachycardia (VT) because it offers a non-invasive way to map heart arrhythmias with greater precision. Unlike traditional VT ablation, which relies heavily on invasive methods and standard imaging, this approach uses computational electrocardiography and cardiac computed tomography mapping to provide detailed arrhythmia targeting information. This enhanced accuracy can potentially lead to more effective ablation procedures, reducing risks and improving outcomes for patients. By incorporating these cutting-edge imaging techniques, doctors can better localize the problematic heart tissue, making the treatment process both safer and more efficient.

What evidence suggests that this imaging technology is effective for ventricular tachycardia?

Research has shown that non-invasive heart imaging techniques, such as ECG and CT scans, hold promise for guiding treatments for ventricular tachycardia (VT). In this trial, participants will undergo VT ablation guided by supplemental non-invasive computational imaging analysis. One study developed a method that combines heart activity mapping with computer analysis of CT scans to accurately locate VT sources. Another report described a case where this method successfully identified VT origins, demonstrating its potential in real-life situations. These advanced imaging tools have improved the planning and accuracy of VT treatments. Overall, these technologies could make VT treatments more precise and safer. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

heartrhythmjournal.com

heartrhythmjournal.com/article/S1547-5271(24)00931-7/fulltext

PO-01-147 OUTCOMES OF NON-INVASIVE ARTIFICIAL ...

We developed a novel non-invasive VT mapping technique integrating computational 12-lead ECG mapping with AI-based CT wall thinning analysis to localize VT ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10240275/

Successful Noninvasive 12-Lead ECG Mapping-Guided ...

We describe a case in which a novel noninvasive computational electrocardiogram mapping algorithm localized VT sources originating from ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S266650182100163X

Computational ECG mapping and respiratory gating to ...

A workflow including computational ECG mapping and protocol-guided respiratory gating is feasible, is safe, and may improve the ease of SAbR planning.

4.

jacc.org

jacc.org/doi/10.1016/j.jacep.2024.08.003

Imaging to Facilitate Ventricular Tachycardia Ablation

Cardiac magnetic resonance, computed tomography and positron emission tomography have emerged as valuable tools in the periprocedural evaluation of VT ablation.

5.

clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/trial/NCT06964152

Computational Cardiac Imaging Analysis to Guide Ventricular ...

The purpose of this study is to evaluate the clinical outcomes (clinical efficacy and safety) of using supplemental non-invasive ...

6.

heartrhythmjournal.com

heartrhythmjournal.com/article/S1547-5271(25)00204-8/fulltext

Ventricular tachycardia substrate mapping: What's been ...

Substrate mapping is an important component of electrophysiological (EP) study for the treatment of reentrant ventricular tachycardia (VT).

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11983391/

Outcomes of ventricular tachycardia ablation facilitated by ...

This prospective registry aimed to analyse procedural data and outcomes in a multi-centre setting of a pre-defined VT ablation strategy.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405500X20307143

Safety and Outcomes of Ventricular Tachycardia Substrate ...

This study sought to analyze safety and outcomes of ventricular tachycardia (VT) substrate ablation during sinus rhythm (SR), without baseline VT induction.