Virtual Heart Guided Ablation for Ventricular Tachycardia

(AVERT-VT Trial)

Overseen By Jonathan Chrispin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Low GFR, Pregnancy, Non-scar VT, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treat ventricular tachycardia (VT), a condition where the heart beats too fast due to scarring. Researchers use a "virtual heart" to help doctors identify the best spots for ablation, a procedure that destroys small areas of heart tissue to restore normal rhythm. By targeting these precise spots, they aim to improve treatment success and reduce procedure time. Individuals with VT linked to heart scarring who can undergo an MRI before the procedure might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future VT treatments.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this imaging/simulation approach is safe for patients with ventricular tachycardia?

Research has shown that noninvasive cardiac radioablation, similar to the Virtual Heart Guided Ablation, is generally well-tolerated. For example, one study found good short-term results for people with recurring ventricular tachycardia (VT), a condition where the heart beats too fast. Administered on a "compassionate use" basis to those with no other options, patients managed it well.

Another study examined the safety of a special approach to treat VT during a normal heart rhythm. This study suggested that the procedure was safe and had positive outcomes.

These findings provide some insight into the potential safety of the Virtual Heart Guided Ablation. While specific safety data for this exact treatment is not available, similar methods have proven manageable with few short-term risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Heart Guided Ablation for ventricular tachycardia because it offers a cutting-edge approach using advanced 3D heart modeling to guide the procedure. Unlike traditional methods, which often rely on the physician's experience and general imaging, this technique provides a personalized map of the heart, potentially improving precision and outcomes. By tailoring the ablation process to the patient's unique heart structure, it aims to increase the effectiveness of the treatment and reduce the risk of complications, making it a promising alternative to standard catheter ablation techniques.

What evidence suggests that the Virtual Heart Guided Ablation is effective for ventricular tachycardia?

Research has shown that the Virtual Heart Guided Ablation technique, which participants in this trial will receive, could be promising for treating ventricular tachycardia (VT), a type of fast and irregular heartbeat. One study using noninvasive cardiac radioablation found that 94% of patients experienced fewer VT episodes or related heart problems. This method uses advanced imaging and simulation to accurately identify the areas in the heart that need treatment. It involves removing small sections of heart tissue to stop abnormal electrical signals. Early results suggest this approach can effectively control VT and might expedite the treatment process. Although more research is needed, these initial findings are encouraging for those seeking new VT treatment options. ^{1 2 4 5 6}

Who Is on the Research Team?

Jonathan Chrispin, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with a rapid heartbeat condition called Ventricular Tachycardia (VT) due to heart scarring. They must have had an MRI scan showing this scarring and be considered suitable for ablation therapy by their heart doctors. People with very poor kidney function, pregnant women, or those who can't undergo an MRI are excluded.

Inclusion Criteria

I have ventricular tachycardia due to heart scarring.

You need to have a specific type of heart MRI before the procedure. If you have a pacemaker or defibrillator from Johns Hopkins University, you may be eligible.

My heart specialist agrees I am a good candidate for VT ablation.

Exclusion Criteria

If a pre-procedure MRI cannot or likely will not be performed for any reason (such as claustrophobia), the patient must be excluded.

I am not pregnant, as the study requires an MRI with a contrast that is unsafe for pregnancy.

If you have a certain type of heart problem that is found during the pre-procedure imaging, you cannot take part in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ablation Procedure

Participants undergo the ablation procedure using the virtual heart approach to determine optimal ablation sites

Time of procedure

Follow-up

Participants are monitored for safety and effectiveness after the ablation procedure

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Heart Guided Ablation

Trial Overview The study tests a new 'virtual heart' imaging/simulation method to find the best spots in the heart to perform ablation on patients with VT. It aims to see if targeting these sites helps stop VT and reduces the time needed for the procedure.

How Is the Trial Designed?

Group I: Virtual Heart Guided Ablation Experimental Treatment 1 Intervention

Virtual Heart Guided Ablation is already approved in United States, European Union for the following indications:

Approved in United States as Virtual Heart Guided Ablation for:

• Ventricular tachycardia (VT)

Approved in European Union as Electrophysiology-guided cardiac radioablation for:

• Refractory ventricular tachycardia (VT)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Substrate-based ablation strategies for ventricular tachycardia (VT) in patients with structural heart disease have been shown to improve outcomes compared to traditional methods that focus solely on mapped VTs.

These strategies include targeting abnormal electrograms, anatomical conduction channels, and areas of slow conduction, each with its own strengths and weaknesses, highlighting the evolution of VT treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substrate-based approaches in ventricular tachycardia ablation. Hawson, J., Al-Kaisey, A., Anderson, RD., et al.[2022]

Non-invasive stereotactic radioablation shows promising short-term efficacy in suppressing ventricular tachycardia (VT) in patients who cannot undergo catheter-based ablation or have had unsuccessful procedures.

The treatment has tolerable side effects, making it a potentially safer alternative for managing VT, as discussed in the review of current clinical evidence and expert consensus on treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radioablation for ventricular tachycardia. Hohmann, S., Hillmann, HAK., Müller-Leisse, J., et al.[2022]

Focused radiotherapy for ablation of cardiac tissue shows promise in reducing the burden of ventricular tachycardia (VT) in patients with structural heart disease, as indicated by early case series.

Concerns about the safety of this technique arise from potential late effects of radiation on critical structures near the heart, highlighting the importance of careful dose modeling to minimize risks during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy for ablation of ventricular tachycardia: Assessing collateral dosing. John, RM., Shinohara, ET., Price, M., et al.[2019]

Contrast-enhanced cardiac MRI can be safely used in patients with implanted cardioverter-defibrillators (ICDs) to create detailed 3D scar maps, which can enhance the accuracy of ventricular tachycardia (VT) ablation procedures.

The integration of MRI-derived scar visualization into clinical mapping systems helps identify optimal ablation sites and reduces the risk of misinterpreting low voltage recordings, improving the overall efficacy of VT ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-Guided ventricular tachycardia ablation: integration of late gadolinium-enhanced 3D scar in patients with implantable cardioverter-defibrillators. Dickfeld, T., Tian, J., Ahmad, G., et al.[2019]

Substrate-guided mapping and ablation during sinus rhythm can effectively treat patients with structural heart disease who have unstable ventricular tachycardias that are not suitable for conventional mapping techniques.

This approach allows for the elimination of multiple ventricular tachycardias and has been linked to improved patient outcomes, although there is currently no standardized method for performing substrate-guided ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach to ablation of unmappable ventricular arrhythmias. Fernández-Armenta, J., Penela, D., Acosta, J., et al.[2022]

Ablation is an effective first-line therapy for idiopathic ventricular tachycardias, showing high efficacy and very low risk of complications, making it a safe option for patients.

For scar-related ventricular tachycardias, while ablation can be performed, the recurrence rate is significant, indicating that it should be used alongside medical therapy and implantable devices for optimal management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal ablation strategies for different types of ventricular tachycardias. Yamada, T., Kay, GN.[2021]

In a study involving 23 patients with ventricular tachycardia (VT) after myocardial infarction, a refined approach using the CARTO system for substrate modification showed a significantly higher success rate in preventing VT when the initial target site was identified with specific criteria (approach one) compared to an alternative method (approach two).

The refined approach not only improved the success rate of ablation (13 out of 16 patients vs. 2 out of 7) but also aimed to reduce overall procedure time and fluoroscopy exposure, enhancing the efficiency of VT treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refinement of CARTO-guided substrate modification in patients with ventricular tachycardia after myocardial infarction. Li, YG., Wang, QS., Grönefeld, G., et al.[2008]

In a study of 207 patients undergoing substrate-based ventricular tachycardia (VT) ablation, there was a significant 99.6% reduction in VT burden and a 96.3% decrease in ICD shocks after the procedure, despite a 41.4% recurrence rate over an average follow-up of 3.14 years.

Patients who experienced VT recurrences still showed a 69.2% decrease in VT episodes, and factors such as lower left ventricular ejection fraction and persistence of late potentials were identified as predictors of recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventricular tachycardia burden reduction after substrate ablation: Predictors of recurrence. Quinto, L., Sanchez-Somonte, P., Alarcón, F., et al.[2022]

Citations

1. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(23)02194-X/fulltext

LB-456090-3 LONG-TERM RESULTS FROM A ... The RADIATE-VT multicenter randomized clinical trial will compare the safety & efficacy of noninvasive cardiac radioablation to repeat catheter ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.038261

Phase I/II Trial of Electrophysiology-Guided Noninvasive ... Of 18 evaluable patients, any reduction in ventricular tachycardia or premature ventricular contractions occurred in 17 (94%), with a concurrent ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1613773

Noninvasive Cardiac Radiation for Ablation of Ventricular ... We combined these techniques to perform catheter-free, electrophysiology-guided, noninvasive cardiac radioablation for ventricular tachycardia.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6331281/

Phase I/II Trial of Electrophysiology-Guided Noninvasive ... Here we describe the results of a prospective trial of noninvasive cardiac radioablation for the control of treatment-refractory VT. METHODS.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X25000435

Safety and Efficacy of Stereotactic Cardiac Radio-Ablation ... Noninvasive stereotactic CRA is well tolerated with good short-term efficacy for recurrent VT on a “compassionate use” basis.

6. jacc.org jacc.org/doi/10.1016/j.jacep.2020.07.028

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.