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

30 Participants Needed

Trial Summary

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 data supports the idea that Virtual Heart Guided Ablation for Ventricular Tachycardia is an effective treatment?

The available research shows that Virtual Heart Guided Ablation, which uses advanced mapping techniques to target areas of the heart causing ventricular tachycardia, has been effective in reducing the frequency of these episodes. For example, early studies using radiotherapy for ablation have shown a consistent decrease in the burden of ventricular tachycardia, indicating that this treatment can effectively manage the condition. Additionally, substrate-based approaches, which focus on targeting specific areas of the heart tissue, have been shown to improve outcomes compared to traditional methods. These findings suggest that Virtual Heart Guided Ablation is a promising treatment for ventricular tachycardia. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Virtual Heart Guided Ablation for Ventricular Tachycardia?

Research shows that substrate-based ablation strategies, which are part of the Virtual Heart Guided Ablation treatment, have improved outcomes in treating ventricular tachycardia by targeting areas of the heart that cause irregular rhythms. Additionally, early studies on using radiotherapy for ablation have shown a consistent decrease in ventricular tachycardia episodes, suggesting potential effectiveness. ^{1 2 3 4 5}

What safety data exists for Virtual Heart Guided Ablation for Ventricular Tachycardia?

The safety data for Virtual Heart Guided Ablation, also known as substrate-based ablation or electrophysiology-guided cardiac radioablation, includes several studies. MRI-guided VT ablation integrates 3D scar reconstruction to facilitate the procedure, which is used in patients with implantable cardioverter-defibrillators. Radiotherapy for VT ablation has shown a consistent decrease in VT burden with sufficient acute safety, though concerns about late effects on critical structures remain. Substrate-based ablation is a first-line treatment for VT in patients with structural heart disease, but recurrence is common. Stereotactic radioablation is a non-invasive option with promising short-term efficacy and tolerable side effects, though more detailed multicenter studies are needed to fully assess safety. ^{2 3 5 6 7}

Is Virtual Heart Guided Ablation for Ventricular Tachycardia safe for humans?

Early studies on similar treatments, like stereotactic radioablation for ventricular tachycardia, show promising short-term safety with tolerable side effects, but there are concerns about the long-term effects of radiation on nearby heart structures. ^{2 3 5 6 7}

Is Virtual Heart Guided Ablation a promising treatment for Ventricular Tachycardia?

Yes, Virtual Heart Guided Ablation is a promising treatment for Ventricular Tachycardia. It uses advanced techniques to target and treat the heart areas causing the problem, which can lead to better outcomes and reduce the frequency of the condition. ^{1 2 4 5 8}

How is Virtual Heart Guided Ablation different from other treatments for ventricular tachycardia?

Virtual Heart Guided Ablation is unique because it uses a virtual model of the heart to guide the ablation process, allowing for precise targeting of the heart tissue responsible for ventricular tachycardia. This approach can be more effective than traditional methods, especially when the arrhythmia is difficult to map or sustain during the procedure. ^{1 2 4 5 8}

What is the purpose of this trial?

The goal of this study is to test the efficacy of the new imaging/simulation ("virtual heart") approach for determining the optimal ablation sites in patients with VT, which render post-infarction VT non-inducible. The study will test both the acute outcome of the ablation procedure, and the effect the use of the predicted targets has upon procedure time.

Research Team

Jonathan Chrispin, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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.

I have ventricular tachycardia due to heart scarring.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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-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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

Refinement of CARTO-guided substrate modification in patients with ventricular tachycardia after myocardial infarction. [2008]

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

Radiotherapy for ablation of ventricular tachycardia: Assessing collateral dosing. [2019]

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

MRI-Guided ventricular tachycardia ablation: integration of late gadolinium-enhanced 3D scar in patients with implantable cardioverter-defibrillators. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Substrate-based approaches in ventricular tachycardia ablation. [2022]

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

Approach to ablation of unmappable ventricular arrhythmias. [2022]

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

Ventricular tachycardia burden reduction after substrate ablation: Predictors of recurrence. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic radioablation for ventricular tachycardia. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Optimal ablation strategies for different types of ventricular tachycardias. [2021]