SBRT for Ventricular Tachycardia

Overseen By John Sapp, MD FRCPC

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: John Sapp

Must be taking: Class III antiarrhythmics

Disqualifiers: Pregnancy, Inotrope-dependent heart failure, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating ventricular tachycardia (VT), a serious heart rhythm issue. It employs stereotactic body radiotherapy (SBRT), a non-invasive technique that precisely targets the heart's scar tissue causing VT with radiation, a method already used in cancer treatment. The trial seeks individuals with heart disease who have experienced multiple VT episodes despite treatments like medication or ablation. This new approach may offer hope to those who haven't found relief with standard treatments. As an unphased trial, it provides patients the opportunity to explore innovative treatment options that might succeed where others have not.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have tried a class III antiarrhythmic drug, which suggests you might need to continue or have a history with such medications.

What prior data suggests that this technique is safe for treating ventricular tachycardia?

Research has shown that stereotactic body radiotherapy (SBRT) is generally well-tolerated by patients with ventricular tachycardia (VT) who haven't responded to other treatments. In one study, none of the deaths were directly linked to SBRT, suggesting the therapy is relatively safe. Additionally, SBRT reduced the number of VT episodes over the year following treatment. This indicates it could lower the frequency of heart rhythm problems without causing significant harm.

In summary, SBRT appears to be a promising and safe option for those who haven't found relief with traditional VT treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic Body Radiotherapy (SBRT) for treating ventricular tachycardia because it offers a non-invasive alternative to current treatments like antiarrhythmic drugs and catheter ablation. Unlike traditional methods, SBRT uses focused radiation beams to precisely target the heart tissue responsible for the arrhythmia, potentially reducing side effects and recovery time. This innovative approach could provide faster relief and improved safety for patients who don't respond well to existing treatments.

What evidence suggests that SBRT is effective for ventricular tachycardia?

Research has shown that stereotactic body radiotherapy (SBRT), which participants in this trial will receive, can reduce episodes of ventricular tachycardia (VT) in patients who haven't responded to standard treatments. Studies indicate that many patients experience fewer VT episodes in the year following SBRT. This therapy targets the heart's scar tissue that causes VT, helping to control the condition. Importantly, SBRT is non-invasive, meaning it doesn't involve surgery, and it has proven safe for patients at high risk. Overall, SBRT offers a promising alternative to more invasive treatments. ^{1 2 3 5 6}

Who Is on the Research Team?

James Clarke, MD FRCPC

Principal Investigator

Nova Scotia Health Authority

John L Sapp, MD FRCPC

Principal Investigator

Nova Scotia Health Authority

James Robar, Phd FCCPM

Principal Investigator

Nova Scotia Health Authority

Jean-Philippe Pignol, MD FRCPC

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for people with heart conditions like a heart attack or ventricular tachycardia, who've tried other treatments without success. They must have had specific types of VT events despite medication and possibly catheter ablation. Pregnant individuals, those with life expectancy under one year (excluding VT), recent acute coronary syndrome, or prior radiotherapy in the treatment area cannot join.

Inclusion Criteria

I have heart disease shown by imaging to affect heart muscle function or show scarring.

I have had multiple specific heart rhythm problems despite treatment.

Exclusion Criteria

I have not had a recent heart attack or severe chest pain due to heart issues.

I have a type of irregular heartbeat known as polymorphic VT or VF.

I have severe heart failure or am expected to live less than a year without treatment for VT.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging and Planning

Clinical imaging data, medical history, and previous ablation data are collected for treatment planning. Further imaging includes 4D cardiac CT, cardiac MRI, and planning CT.

2-3 weeks

2 visits (in-person)

SBRT Treatment

Patients undergo stereotactic body radiotherapy (SBRT) using a TrueBeam 1 linear accelerator. Treatment administration takes approximately 30 minutes.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up occurs at 6 & 12 weeks, 7.5 months, then every 6 months.

7.5 months to 2 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiotherapy (SBRT)

Trial Overview The study tests Stereotactic Body Radiotherapy (SBRT) as a non-invasive option to target and treat areas of the heart responsible for causing dangerous rapid heartbeats known as ventricular tachycardia (VT). It aims to provide an alternative when standard therapies like drugs or invasive procedures fail.

How Is the Trial Designed?

Group I: Imaging & SBRT Treatment for Ventricular Tachycardia Experimental Treatment 1 Intervention

Stereotactic Body Radiotherapy (SBRT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer

Who Is Running the Clinical Trial?

John Sapp

Lead Sponsor

Trials

6

Recruited

730+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) is a promising non-invasive treatment for ventricular tachycardia (VT), particularly in cases where traditional methods like catheter ablation and anti-arrhythmic drugs fail.

In a reported case, a patient experiencing an electrical storm from incessant VT showed an immediate and lasting improvement after receiving electrophysiology-guided cardiac SBRT, highlighting its potential efficacy in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rescue procedure for an electrical storm using robotic non-invasive cardiac radio-ablation. Jumeau, R., Ozsahin, M., Schwitter, J., et al.[2018]

Cardiac stereotactic body radiotherapy (SBRT) has shown promising safety and effectiveness in treating refractory ventricular tachycardia (VT), with a significant reduction in VT burden of 98% at 6 months and 99% at 12 months after treatment in a study of 14 patients.

Despite some recurrence of VT in 33% of patients, SBRT demonstrated a favorable safety profile with no changes in ventricular function and a trend towards reduced amiodarone use, indicating its potential as a noninvasive treatment option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Outcomes Following Stereotactic Body Radiotherapy for Refractory Ventricular Tachycardia. Arkles, J., Markman, T., Trevillian, R., et al.[2023]

In a study of eight male patients with refractory ventricular tachycardia (VT), stereotactic body radiation therapy (SBRT) was found to significantly reduce the frequency of VT episodes, with a decrease in ICD therapies from a median of 69.5 to 13.3 after treatment (p=0.036).

The treatment was well-tolerated with no acute complications reported, and the average radiation dose delivered was 22.2 Gy in a single session, suggesting that SBRT is a safe and potentially effective option for managing refractory VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive stereotactic body radiation therapy for refractory ventricular arrhythmias: an institutional experience. Chin, R., Hayase, J., Hu, P., et al.[2022]

In a study of 10 advanced heart failure patients treated with stereotactic body radiation therapy (SBRT), there was a significant 69% reduction in the total duration of ventricular tachycardia (VT) detected by implantable cardioverter-defibrillators (ICDs) after treatment.

SBRT also led to a 68% reduction in the number of ICD shocks and a 48% decrease in antitachycardia pacing sequences, indicating that this noninvasive treatment can effectively reduce the burden of VT in patients who are refractory to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience of stereotactic body radiation for refractory ventricular tachycardia in advanced heart failure patients. Lloyd, MS., Wight, J., Schneider, F., et al.[2021]

Stereotactic body radiotherapy (SBRT) is being explored as a non-invasive treatment option for ventricular tachycardia (VT) caused by myocardial scarring, which is traditionally managed with antiarrhythmic drugs and catheter ablation that have limited effectiveness and potential side effects.

This review discusses the principles and early results from trials and case series that suggest SBRT may offer a promising alternative for patients with VT that does not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Radiotherapy for the Management of Refractory Ventricular Tachycardia: Promise and Future Directions. Jumeau, R., Ozsahin, M., Schwitter, J., et al.[2020]

Stereotactic body radiotherapy (SBRT) is a highly precise and effective non-invasive treatment commonly used for solid tumors, and it is now being explored for treating ventricular tachycardia (VT).

Clinical studies have demonstrated the potential of SBRT in managing VT, indicating a promising new application of this technology beyond traditional oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of refractory ventricular tachycardia using stereotactic body radiotherapy]. Jumeau, R., Bourhis, J., Ozsahin, M., et al.[2019]

A patient with refractory ventricular tachycardia (VT) was treated with a single fraction of 12 Gy stereotactic body radiation therapy (SBRT), which resulted in no observed acute or late toxicity, indicating a potentially safer approach compared to higher doses.

Post-treatment imaging showed that the targeted area transformed into scar tissue, suggesting that SBRT may effectively modify the heart's electrical substrate, although the patient later developed a new type of VT, highlighting the need for further research on long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Stereotactic body radiation therapy with 12 Gy for silencing refractory ventricular tachycardia. Huang, SH., Wu, YW., Shueng, PW., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37827346/

One-year outcomes after stereotactic body radiotherapy for ... Conclusion: For a select group of high-risk patients with VT refractory to standard therapy, SBRT is associated with a reduction in VT and appropriate ICD ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1547527123027820

One-year outcomes after stereotactic body radiotherapy for ... SBRT for a select group of patients who have failed maximal traditional therapy is associated with a reduction in treated VT episodes over the next 12 months. A ...

3. redjournal.org redjournal.org/article/S0360-3016(25)03542-4/fulltext

Stereotactic Body Radiation Therapy for Ventricular ... At last follow-up, 62% of patients had died, none directly related to SBRT. Compared to 30 days prior to SBRT, median change in average 30-day-rate of VT burden ...

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

A systematic review and meta-analysis of prospective trials ... Data from prospective trials on stereotactic arrhythmia radioablation (STAR) for ventricular tachycardia (VT), also known as cardiac ...

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

Stereotactic Radioablation for Ventricular Tachycardia in ... Stereotactic body radiotherapy (SBRT) has been reported as a safe and efficient therapy for treating refractory ventricular tachycardia (VT) ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(23)02782-0/abstract

One-year outcomes after stereotactic body radiotherapy for ... Fourteen (93%) underwent treatment, with 12 (80%) surviving to the end of the 6-week period and 10 (67%) surviving to 12 months. From 6 week to ...