Imaging for Ventricular Tachycardia

(ITPCR Trial)

Overseen By Stewart Gaede, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stewart Gaede

Disqualifiers: Polymorphic VT, Ventricular fibrillation, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Cardiac Radioablation for Ventricular Tachycardia?

Research shows that cardiac radioablation can reduce episodes of ventricular tachycardia (a type of fast heart rhythm) by more than 85% in patients, with promising short-term safety. This treatment is especially considered for patients who cannot undergo or have not benefited from other procedures like catheter ablation. ^{1 2 3 4 5}

Is cardiac radioablation safe for humans?

Research suggests that cardiac radioablation, also known as stereotactic arrhythmia radioablation (STAR), is generally safe for treating ventricular tachycardia, with studies showing promising short-term safety profiles and tolerable side effects. ^{1 2 3 5 6}

How does cardiac radioablation differ from other treatments for ventricular tachycardia?

Cardiac radioablation is a novel, non-invasive treatment for ventricular tachycardia, especially for patients who cannot undergo or have not benefited from catheter ablation. It uses targeted radiation to treat the heart tissue responsible for the arrhythmia, offering a promising alternative with good short-term efficacy and manageable side effects. ^{2 3 4 7 8}

What is the purpose of this trial?

The purpose of this study is to (1) determine whether computed tomography (CT) imaging can be used to identify areas of ischemic scar, which are often used as radiation targets for cardiac radioablation, just as well as MRI can, and (2) to determine how best to deliver cardiac radioablation treatment to a patient, for example, which treatment machine should be used and how to limit the effect of chest movement during treatment. Participants will undergo two separate imaging appointments: one CT imaging appointment, where they will undergo scans including perfusion scans, late enhancement scans, and radiation therapy treatment planning scans; and one MRI appointment, where they will undergo scans including a late enhancement scan. The overlap in areas of ischemic scar as identified in CT scans and MRI scans will be quantified. Using radiation therapy treatment planning CT scans, the safety and feasibility of different treatment and motion management techniques will be evaluated. Treatment plans will be created using these different techniques and will be compared to one another. These plans will also be evaluated for compliance with dose constraints.

Eligibility Criteria

This trial is for individuals with various types of Ventricular Tachycardia (VT), a heart condition characterized by fast heart rhythms. Participants should be suitable candidates for cardiac imaging and radioablation therapy, but specific inclusion criteria are not provided here.

Inclusion Criteria

Referred by cardiologists

I have a type of heart disease with regular abnormal heartbeats.

Exclusion Criteria

I have a type of irregular heartbeat called polymorphic ventricular tachycardia.

I have experienced ventricular fibrillation.

Unable to undergo MRI due to metal implants

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo CT and MRI imaging to identify areas of ischemic scar

1-2 weeks

2 visits (in-person)

Treatment Planning

Treatment plans are created using CT scans with various techniques and evaluated for compliance with dose constraints

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment planning

6 months

Treatment Details

Interventions

• Cardiac Radioablation

Trial Overview The study aims to compare CT imaging to MRI in identifying ischemic scars used as targets for cardiac radioablation. It also seeks the best methods for delivering this treatment while managing chest movement during therapy.

Participant Groups

Group I: CT and MRI Experimental Treatment 1 Intervention

All participants will undergo both CT imaging and MRI imaging to identify areas of ischemic scar. Treatment plans will be created based on CT scans, using various treatment delivery and motion management techniques.

Who Is Running the Clinical Trial?

Stewart Gaede

Lead Sponsor

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

London Health Science Centre

Collaborator

St. Joseph's Health Care London

Collaborator

Trials

28

Recruited

2,500+

Findings from Research

Radioablation has shown promising results in reducing ventricular arrhythmias, with over 85% reduction in arrhythmia episodes in patients and significant electrophysiological improvements in animal studies, including a 75% reduction in ventricular arrhythmia inducibility.

Despite these encouraging outcomes, the overall evidence for the efficacy and safety of radioablation is limited, highlighting the need for further research to better understand its long-term effects and optimal application in therapy-refractory patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac radioablation-A systematic review. van der Ree, MH., Blanck, O., Limpens, J., et al.[2021]

In a study of 6 patients treated with noninvasive cardiac radioablation for ventricular tachycardia (VT), there was a significant reduction in the burden of ventricular beats, with a 49% decrease within 24 hours and a 70% decrease at 1 month post-treatment.

Long-term follow-up showed that 5 out of 6 patients experienced complete or partial remission of their ventricular arrhythmias, indicating that cardiac radioablation is both effective and safe for managing intractable VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term and long-term effects of noninvasive cardiac radioablation for ventricular tachycardia: A single-center case series. Chang, WI., Jo, HH., Cha, MJ., et al.[2023]

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]

Cardiac radioablation is a promising treatment for patients with refractory ventricular tachycardia, showing feasibility across different treatment planning systems, including robotic arm and C-arm LINACs, with comparable plan quality.

Significant variability in dose distribution was observed among treatment plans, highlighting the need for standardized guidelines to optimize treatment outcomes, particularly concerning cardiac substructures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Planning for Cardiac Radioablation: Multicenter Multiplatform Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. Kluge, A., Ehrbar, S., Grehn, M., et al.[2022]

In a prospective trial involving 11 patients with recurrent ventricular tachycardia (VT), stereotactic arrhythmia radioablation (STAR) demonstrated a safety profile with only one patient experiencing a significant treatment-related adverse event, indicating it is a relatively safe option for this condition.

STAR resulted in an 84.3% reduction in VT burden among evaluable patients, suggesting it is an effective treatment for selected patients with VT, although many experienced recurrence and further interventions were needed, highlighting the need for long-term outcome studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. Miszczyk, M., Sajdok, M., Bednarek, J., et al.[2023]

Cardiac radioablation is a promising treatment for patients with therapy-refractory ventricular tachycardia (VT) who cannot undergo catheter ablation, but it requires precise definition of the clinical target volume (CTV) based on electroanatomical mapping (EAM).

A study involving data from three cases across five university centers revealed significant variability in CTV definitions, highlighting the need for standardized protocols to ensure consistency in multicenter clinical trials like the RAVENTA trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary Clinical Target Volume Generation for Cardiac Radioablation: Multicenter Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. Boda-Heggemann, J., Blanck, O., Mehrhof, F., et al.[2021]

References

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

Cardiac radioablation-A systematic review. [2021]

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

Short-term and long-term effects of noninvasive cardiac radioablation for ventricular tachycardia: A single-center case series. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic radioablation for ventricular tachycardia. [2022]

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

Treatment Planning for Cardiac Radioablation: Multicenter Multiplatform Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. [2022]

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

Standardizing the Cardiac Radioablation Targeting Workflow: Enabling Semi-Automated Angulation and Segmentation of the Heart According to the American Heart Association Segmented Model. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. [2023]

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

Interdisciplinary Clinical Target Volume Generation for Cardiac Radioablation: Multicenter Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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