Radiotherapy for Arrhythmias

Overseen By Benjamin Lok, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Prior high dose radiotherapy, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, single-center, phase II trial that will be monitoring the safety and efficacy of using stereotactic ablative radiotherapy (SBRT) to treat patients with a medical condition affecting heart rate and rhythm (refractory arrhythmias) within the University Health Network (Princess Margaret Cancer Centre and Toronto General Hospital). The primary objective will be to prospectively monitor patient cardiac outcomes following SBRT.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Stereotactic Ablative Radiotherapy, Stereotactic Body Radiotherapy (SBRT), Stereotactic Ablative Body Radiotherapy for arrhythmias?

Research shows that Stereotactic Body Radiotherapy (SBRT) is effective in treating ventricular tachycardia (a type of fast heart rhythm) that doesn't respond to other treatments, with patients experiencing immediate and lasting improvements. ^{1 2 3 4 5}

Is stereotactic body radiotherapy (SBRT) safe for treating arrhythmias?

Initial studies have shown that stereotactic body radiation therapy (SBRT) is generally safe for treating refractory ventricular tachycardia, a type of arrhythmia, in humans. ^{2 3 4 5 6}

How is the treatment Stereotactic Ablative Radiotherapy different from other treatments for arrhythmias?

Stereotactic Ablative Radiotherapy (SBRT) is a unique, non-invasive treatment for arrhythmias like ventricular tachycardia, especially when other treatments like catheter ablation and drugs don't work. It uses precise radiation to target the heart tissue causing the arrhythmia, offering a new option for patients with difficult-to-treat conditions. ^{1 3 4 5 7}

Eligibility Criteria

The START-CA trial is for patients with stubborn heart rate and rhythm problems (arrhythmias) who haven't improved after standard treatments or at least one invasive procedure. They must be healthy enough for stereotactic ablative radiotherapy, as judged by a Radiation Oncologist, but can't join if they've had high dose radiotherapy to the target area before or have other reasons they can't undergo this therapy.

Inclusion Criteria

You have a heart rhythm problem (arrhythmia) that hasn't improved with medication or a previous procedure.

Patients deemed medically fit to receive stereotactic ablative radiotherapy as determined by their Radiation Oncologist.

Exclusion Criteria

You have already had strong radiation treatment in the same area and cannot have more treatment, or there are other reasons why you can't have radiation treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

A single treatment of stereotactic ablative radiotherapy (SBRT) is delivered to the abnormal area of a participant's heart

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cardiac outcomes and quality of life assessments

18 months

Follow-up visits at 1, 3, 6, 12, and 18 months

Treatment Details

Interventions

• Stereotactic Ablative Radiotherapy

Trial Overview This phase II trial at University Health Network is testing how safe and effective it is to use stereotactic ablative radiotherapy (SBRT) on patients with refractory arrhythmias. It's a forward-looking study that will closely watch how patients' hearts do after getting SBRT.

Participant Groups

Group I: Stereotactic ablative radiotherapy (SBRT) Arm Experimental Treatment 1 Intervention

Stereotactic ablative radiotherapy (SBRT) is a type of radiation treatment that delivers precise, high dose radiation to targeted areas. In this study, a single treatment of SBRT will be delivered to the abnormal area of a participant's heart that is causing dangerous heart rate and rhythm changes (arrhythmia).

Group II: Observational Arm Active Control 1 Intervention

Potential participants who are eligible to be included in the study, but who choose not to have the SBRT procedure, can still receive standard medical treatment alone and be followed up with study visits and questionnaires.

Stereotactic Ablative Radiotherapy is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United States as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United Kingdom as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

Stereotactic body radiotherapy (SBRT) can effectively eliminate recurrent ventricular tachycardia (VT) in patients who do not respond to conventional treatments, as demonstrated in a case study of a 66-year-old man with a history of heart disease.

The successful outcome of SBRT in this patient was achieved through a novel targeting method that integrated electroanatomical mapping with CT imaging, emphasizing the importance of precise targeting in the treatment of VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case report of successful elimination of recurrent ventricular tachycardia by repeated stereotactic radiotherapy: the importance of accurate target volume delineation. Peichl, P., Sramko, M., Cvek, J., 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]

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 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]

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) for ultra-central lung tumors shows high efficacy, with pooled local control rates of 92% at 1 year and 89% at 2 years, based on a systematic review of 27 studies involving 1183 treated targets.

While SBRT is effective, it carries risks of severe toxicity, with a 6% incidence of grade 3-4 toxicities and a 4% incidence of treatment-related deaths, highlighting the importance of careful patient selection and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for Ultra-Central lung Tumors: A systematic review and Meta-Analysis and International Stereotactic Radiosurgery Society practice guidelines. Yan, M., Louie, AV., Kotecha, R., et al.[2023]

A new workflow using the 3D Slicer software allows for high-precision targeting of arrhythmogenic areas in the heart for noninvasive radiotherapy, achieving an average alignment accuracy of 3.1 mm between electroanatomic maps and CT scans.

This method integrates electroanatomic mapping with CT imaging to improve the localization of electrophysiological features, potentially enhancing the effectiveness of stereotactic ablative radiotherapy for cardiac arrhythmias, though further studies are needed to confirm its superiority over existing techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel open-source software-based high-precision workflow for target definition in cardiac radioablation. Hohmann, S., Henkenberens, C., Zormpas, C., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

A case report of successful elimination of recurrent ventricular tachycardia by repeated stereotactic radiotherapy: the importance of accurate target volume delineation. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

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

6. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for Ultra-Central lung Tumors: A systematic review and Meta-Analysis and International Stereotactic Radiosurgery Society practice guidelines. [2023]

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

A novel open-source software-based high-precision workflow for target definition in cardiac radioablation. [2021]