Ablative Radiation for Ventricular Tachycardia

(StAR-VT Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must be taking: Antiarrhythmics

Disqualifiers: Previous RT, Connective tissue disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat ventricular tachycardia (VT), an irregular heartbeat, using precise radiation therapy known as Stereotactic Body Radiotherapy (SBRT). The goal is to determine if a lower dose of this radiation can reduce VT episodes while minimizing side effects. The treatment targets scar tissue in the heart responsible for the irregular beats. Suitable candidates for this trial have previously tried other VT treatments without success and have undergone prior heart studies or treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial summary mentions a decrease in antiarrhythmic drug use, but it does not specify if participants must stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

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

Research has shown that stereotactic body radiotherapy (SBRT) is generally safe for people with ventricular tachycardia (VT), a condition where the heart beats too fast. In past studies, patients who received SBRT experienced fewer VT episodes over a year. These studies focused on patients who didn't respond to other treatments, and the results were promising.

One study found no changes in heart function after treatment. However, a few deaths occurred, highlighting the high-risk nature of the patients studied. The treatment appears effective and well-tolerated, but it is not yet a standard option for VT. More research is needed to determine the best dose and confirm these findings.

In this trial, researchers aim to find the lowest effective dose that works without causing too many side effects. They are testing a lower dose than previously used, aiming to protect healthy tissues around the heart. This careful approach seeks to maintain benefits while reducing risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ventricular tachycardia?

Unlike the standard treatments for ventricular tachycardia, which often involve medications like beta-blockers or invasive procedures such as catheter ablation, stereotactic body radiotherapy offers a non-invasive alternative. This treatment is unique because it delivers a high dose of radiation precisely to the problematic heart tissue in just one session. Researchers are excited about this approach as it promises a quicker recovery time and reduced risk of complications compared to traditional methods. Additionally, its precise targeting might improve the effectiveness of managing this arrhythmia, providing a new hope for patients who are not responsive to existing treatments.

What evidence suggests that this stereotactic body radiotherapy is effective for ventricular tachycardia?

Research has shown that stereotactic body radiotherapy (SBRT) may help with ventricular tachycardia (VT), a fast and irregular heartbeat. In one study with 17 patients, SBRT significantly reduced VT episodes, decreased the need for heart rhythm drugs, and improved quality of life. Another study found that patients whose VT did not respond to other treatments experienced fewer VT episodes and required less anti-tachycardia pacing after receiving SBRT. In this trial, participants will receive SBRT at a dosage of 20 Gy in 1 fraction. These early results suggest that SBRT could benefit patients with hard-to-treat VT, but more research is needed to determine the best dosage and long-term effects. ^{1 2 3 6 7}

Who Is on the Research Team?

Martin L Bernier, MD

Principal Investigator

MUHC division of cardiology

Joanne Alfieri, MD

Principal Investigator

MUHC division of radiation oncology/RIMUHC

Are You a Good Fit for This Trial?

This trial is for adults with heart muscle disease who've had a special heart study and treatment but still experience rapid, irregular heartbeats. It's not for those who've had radiation in the same area before, have certain lung conditions, are pregnant or breastfeeding, or plan to become pregnant.

Inclusion Criteria

I can't have certain heart tests but my heart rhythm issue can be checked without them.

I have a heart condition that affects how my heart muscle functions.

I have had a heart rhythm study and treatment.

Exclusion Criteria

Participants who plan to become pregnant or breast feed during the study duration

I have been diagnosed with interstitial pulmonary fibrosis.

Pregnant or breastfeeding individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive a single fraction of 20 Gy stereotactic body radiotherapy to the arrhythmogenic substrate

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, arrhythmia burden, and quality of life

5 years

Regular visits over 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiotherapy

Trial Overview The StAR-VT trial tests a new way to treat severe irregular heartbeats using targeted body radiotherapy (20 Gy in one session). The goal is to see if this can reduce heartbeat issues with fewer side effects by lowering the dose from previous studies.

How Is the Trial Designed?

Group I: Radiation: 20 Gy in 1 fraction Experimental Treatment 1 Intervention

External beam, stereotactic body radiotherapy of 20 Gy delivered in 1 fraction to the planning target volume (PTV) of the arrhythmogenic substrate

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

Approved in European Union as Stereotactic Body Radiation Therapy for:

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

Approved in United States as Stereotactic Body Radiation Therapy for:

• Early-stage lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in Canada as Stereotactic Body Radiation Therapy for:

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

Approved in Japan as Stereotactic Body Radiation Therapy for:

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

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Published Research Related to This Trial

The use of automated 12-lead ECG mapping and respiratory-gated therapy in stereotactic ablative radiotherapy (SAbR) for refractory ventricular tachycardia (VT) improved planning precision and safety, with no gastrointestinal complications observed in patients with targets near the stomach.

In a study of 6 patients, the approach led to a significant reduction in implantable cardioverter-defibrillator shocks, decreasing from an average of 23 to 0.67 shocks per patient after treatment, indicating effective management of VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computational ECG mapping and respiratory gating to optimize stereotactic ablative radiotherapy workflow for refractory ventricular tachycardia. Ho, G., Atwood, TF., Bruggeman, AR., et al.[2022]

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]

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 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]

Citations

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

One-year outcomes after stereotactic body radiotherapy for ... Objective: The purpose of this study was to describe the safety and effectiveness of SBRT for VT in refractory to extensive ablation. Methods: After maximal ...

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

One-year outcomes after stereotactic body radiotherapy for ... The purpose of this study was to describe the safety and effectiveness of SBRT for VT in refractory to extensive ablation. Methods. After maximal medical and ...

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

One-year outcomes after stereotactic body radiotherapy for ... The purpose of this study was to describe the safety and effectiveness of SBRT for VT in refractory to extensive ablation. Methods. After ...

4. e-roj.org e-roj.org/journal/view.php?number=1619

Reinforcing treatment and evaluation workflow of ... This study aims to establish a consistent institutional workflow for single-fraction cardiac VT-SABR, emphasizing robust plan evaluation and quality assurance.

5. academic.oup.com academic.oup.com/europace/article/27/1/euae305/7931915

Stereotactic cardiac radiotherapy for refractory ventricular ... This study aims to assess the efficacy of cardiac SBRT in refractory VT by comparing the rates of VT episodes, anti-tachycardia pacing (ATP) therapies, and ...

6. 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) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12395866/

Technical aspects of SBRT for therapy-refractory ... SBRT seems safe and effective in reducing VT in first clinical trials, though it is not yet a routine treatment. Further controlled trials with ...