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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating ventricular tachycardia (VT), a condition where scar tissue causes the heart to beat too fast. Researchers are testing new MRI and CT imaging methods to identify these scar areas without surgery. The goal is to demonstrate that these methods can aid in planning safe radiation treatments, such as cardiac radioablation (a type of radiation therapy). Individuals with VT linked to heart damage, referred by a cardiologist, might be suitable candidates for this trial. As an unphased trial, this study provides patients the chance to contribute to groundbreaking research that could enhance future treatment options.

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 prior data suggests that these new imaging protocols are safe for patients with ventricular tachycardia?

Research has shown that cardiac radioablation, which uses radiation to target heart scars causing rapid heartbeats (ventricular tachycardia or VT), is generally well tolerated. Studies have found this noninvasive treatment effective and safe for managing VT. In one study, 94% of patients experienced fewer VT episodes six months after treatment. Another study confirmed the method's safety and good short-term results for people with recurring VT.

However, one study reported a 27% death rate within a year among very sick patients with difficult-to-treat VT, reflecting the severity of their condition rather than the treatment itself.

Overall, cardiac radioablation shows promise, but results can vary based on individual health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cardiac radioablation for ventricular tachycardia because it offers a non-invasive alternative to standard treatments like antiarrhythmic drugs and catheter ablation. Unlike these conventional methods, cardiac radioablation uses precise radiation to target and destroy problematic heart tissue without the need for catheters or incisions. This technique could reduce recovery time and lower the risk of complications associated with invasive procedures. Additionally, by using advanced imaging techniques like CT and MRI, treatment plans are highly personalized, improving the accuracy and potential effectiveness of the therapy.

What evidence suggests that these new imaging protocols are effective for identifying scar tissue in ventricular tachycardia?

Studies have shown that cardiac radioablation, a noninvasive treatment, holds promise for treating ventricular tachycardia (VT). This method uses focused radiation to treat heart scars that cause VT. Research indicates it can reduce VT episodes by about 77% and matches the effectiveness of traditional treatments like catheter ablation. Patients generally tolerate it well, and it shows good short-term success. These findings suggest cardiac radioablation could be a strong option for managing VT. In this trial, participants will undergo both CT and MRI imaging to identify areas of ischemic scar, which will inform the treatment plans for cardiac radioablation. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)02912-6/fulltext

A systematic review and meta-analysis of prospective trials ... In conclusion, STAR is a promising treatment method, characterized by moderate toxicity. We observed 1-year mortality of ≈27% in this population ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625062236

Stereotactic Arrhythmia Radiotherapy (STAR) vs Repeat ... This study demonstrates that stereotactic arrhythmia radiotherapy (STAR) has comparable efficacy to repeat catheter ablation (CA) in controlling ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12105486/

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.

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.122.010955

Stereotactic Radioablation for Ventricular Tachycardia in ... Outcomes. The efficacy was assessed with the following composite end point: sustained VT recurrence (i.e., lasting more than 30 s), VT reduced ...

5. academic.oup.com academic.oup.com/europace/article/doi/10.1093/europace/euaf085.772/8141487

Stereotactic arrhythmia radioablation in refractory ventricular ... The percentage reduction in VT episodes/month was 77.1% (n=89; 95% CI 57.5%-92.8%; I²=65.0%; p<0.001) while this was 81.8% for reduction in ICD ...

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9975004/

Short-term and long-term effects of noninvasive cardiac ... Noninvasive cardiac radioablation is reported to be effective and safe for the treatment of ventricular tachycardia (VT). This study aimed to analyze the ...

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

Phase I/II Trial of Electrophysiology-Guided Noninvasive ... Of the 18 patients who survived 6 months, the primary efficacy end point of reduction in VT episodes or PVC burden was achieved in 17/18 (94%) ...

9. redjournal.org redjournal.org/article/S0360-3016(25)06223-6/fulltext

Stereotactic Arrhythmia Radiation Therapy Versus Repeat ... However, no studies have directly compared the 2 modalities. This study reports 3-year safety and efficacy outcomes for STAR versus CA in ...