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

Trial Summary

What is the purpose of this trial?

Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. Current treatment for VT consists of either implantable defibrillators (ICDs), suppressive drug therapy, catheter ablation or a combination of all 3. Implantable Defibrillators (ICDs) reduce sudden death and can terminate some ventricular tachycardia (VT) without shocks, but they don't prevent VT. The occurrence of ≥1 ICD shock is associated with reductions in mental well-being and physical functioning, and increases in anxiety and sometimes depression. Further, ICD shocks have been consistently associated with adverse outcomes, including heart failure and death. Furthermore, the most important predictor of ICD shocks is a history of prior ICD shocks. Therapies to suppress VT include antiarrhythmic drug therapy and catheter ablation, neither however is universally effective. When VT recurs despite antiarrhythmic drug therapy and catheter ablation, novel yet invasive, approaches may be required. Such invasive procedures carry consequent risks of cardiac and extra-cardiac injury. Stereotactic body radiotherapy (SBRT) is a non-invasive technique that delivers high doses of radiation precisely to specified regions in the body, while minimizing exposure to adjacent tissue. This technique is currently, and commonly used in the treatment of cancer. Conventional application of SBRT has made use of its ability to spare non-target tissue, including for treatment of tumors near the heart. More recently, clinicians have changed the paradigm, by focusing radioablative energy on ventricular scar responsible for ventricular tachycardia. Pre-clinical studies have supported the concept and were followed by first-in-human VT therapeutic experience in 2017. Subsequent studies have had encouraging results for patients who failed or were unable to tolerate conventional treatment.

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 data supports the effectiveness of the treatment Stereotactic Body Radiotherapy (SBRT) for Ventricular Tachycardia?

Research shows that SBRT is effective in treating patients with difficult-to-treat ventricular tachycardia, especially when other treatments like catheter ablation and medications don't work. Studies have reported that patients experienced immediate and lasting improvements after receiving SBRT. ^{1 2 3 4 5}

Is stereotactic body radiation therapy (SBRT) safe for treating ventricular tachycardia?

Initial studies have shown that SBRT is generally safe for treating ventricular tachycardia, with efforts made to reduce long-term heart-related side effects. ^{1 4 5 6 7}

How is the treatment SBRT different from other treatments for ventricular tachycardia?

SBRT is a unique non-invasive treatment that uses precise radiation to target areas of the heart causing ventricular tachycardia, unlike traditional treatments like antiarrhythmic drugs and catheter ablation, which can have limited effectiveness and side effects. ^{1 2 3 4 7}

Research Team

John L Sapp, MD FRCPC

Principal Investigator

Nova Scotia Health Authority

James Clarke, 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

Eligibility Criteria

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

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

Clinical experience of stereotactic body radiation for refractory ventricular tachycardia in advanced heart failure patients. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Rescue procedure for an electrical storm using robotic non-invasive cardiac radio-ablation. [2018]

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

One-Year Outcomes Following Stereotactic Body Radiotherapy for Refractory Ventricular Tachycardia. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Management of refractory ventricular tachycardia using stereotactic body radiotherapy]. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Non-invasive stereotactic body radiation therapy for refractory ventricular arrhythmias: an institutional experience. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Case report: Stereotactic body radiation therapy with 12 Gy for silencing refractory ventricular tachycardia. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Radiotherapy for the Management of Refractory Ventricular Tachycardia: Promise and Future Directions. [2020]