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

9 Participants Needed

Trial Summary

What is the purpose of this trial?

In 2017 a novel treatment approach to a series of 5 patients with refractory VT was introduced, using ablative radiation with a stereotactic body radiation therapy (SBRT) technique to arrhythmogenic scar regions defined by noninvasive cardiac mapping. More recently, Robinson et al. reported on the results of their Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia (ENCORE-VT) trial, also using a similar SBRT technique in a series of 17 patients with refractory VT. Both studies report a marked reduction in VT burden, a decrease in antiarrhythmic drug use, and an improvement in quality of life. Since then, numerous other centres have detailed their initial experience with this technique. These initial results suggest that this new treatment paradigm has the potential to improve morbidity and mortality for patients suffering from treatment-refractory VT by means of a minimally invasive technique, but requires further validation for widespread use. The appropriate dose for therapeutic effect of this new treatment is not well established as only a single dose prescription of 25 Gy in 1 fraction has been described with benefit. In this phase 2 trial, the investigators plan on expanding the experience with this technique but also by contributing to understanding the relationship between dose-effect relationship through a dose de-escalation stratification, to 20 Gy in 1 fraction, with the goal of minimizing possible adverse events and radiation dose to surrounding healthy tissue while maintaining a clinical benefit.

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

Research shows that Stereotactic Body Radiotherapy (SBRT) is effective in treating patients with ventricular tachycardia (VT) that does not respond to other treatments, providing a promising non-invasive option with immediate and lasting results. ^{1 2 3 4 5}

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

Initial studies have reported excellent safety for stereotactic body radiation therapy (SBRT) in patients with refractory ventricular tachycardia. ^{1 2 3 5 6}

How is the treatment Stereotactic Body Radiotherapy (SBRT) different from other treatments for ventricular tachycardia?

Stereotactic Body Radiotherapy (SBRT) is a unique, noninvasive treatment that uses precise radiation to target and treat areas of the heart causing ventricular tachycardia, especially when other treatments like drugs and catheter ablation have failed. Unlike traditional methods, SBRT is typically used in cancer treatment and is now being explored for its precision and effectiveness in managing heart rhythm issues. ^{1 2 5 7 8}

Research Team

Martin L Bernier, MD

Principal Investigator

MUHC division of cardiology

Joanne Alfieri, MD

Principal Investigator

MUHC division of radiation oncology/RIMUHC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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]

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

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

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

Computational ECG mapping and respiratory gating to optimize stereotactic ablative radiotherapy workflow for refractory ventricular tachycardia. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Long Term Follow-Up of Stereotactic Body Radiation Therapy for Refractory Ventricular Tachycardia in Advanced Heart Failure Patients. [2022]

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

Noninvasive Stereotactic Radiation for Refractory Ventricular Tachycardia After Failure of Cardiac Sympathetic Denervation. [2022]