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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat heart rhythm problems using a precise radiation therapy called stereotactic ablative radiotherapy (SBRT). The researchers aim to determine if this treatment can safely and effectively help individuals whose arrhythmias (irregular heartbeats) have not improved with standard treatments like medication or catheter ablation. Participants will either receive SBRT or continue with their usual care for comparison. Suitable candidates have a heart rhythm issue unresponsive to other treatments and are deemed healthy enough by their doctor to receive this type of radiation therapy. As an unphased trial, this study provides patients the opportunity to explore innovative treatment options that could improve their condition when other treatments have failed.

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 prior data suggests that stereotactic ablative radiotherapy (SBRT) is safe for treating refractory arrhythmias?

Research has shown that stereotactic ablative radiotherapy (SBRT) is generally well-tolerated for treating heart rhythm problems. Studies have found that patients often experience fewer episodes of ventricular tachycardia (VT), a type of fast heartbeat, after receiving SBRT.

In one study, patients who lived at least six months after treatment experienced an 81% reduction in VT episodes. Another study found that this type of radiotherapy led to fewer VT episodes over a year.

Overall, these findings suggest that SBRT can be a safe option for people with difficult heart rhythm issues, with many patients handling the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic Ablative Radiotherapy (SBRT) is unique because it delivers highly precise, high-dose radiation directly to the heart area causing arrhythmias. Unlike standard treatments for arrhythmias, which often involve medications or invasive procedures like catheter ablation, SBRT is non-invasive and targets the problem area with pinpoint accuracy. Researchers are excited about this treatment because it could provide a less invasive, more targeted option that potentially reduces recovery time and minimizes risks associated with traditional methods.

What evidence suggests that stereotactic ablative radiotherapy is effective for treating refractory arrhythmias?

Research has shown that stereotactic ablative radiotherapy (SBRT), which participants in this trial may receive, can help treat stubborn heart rhythm problems that don't improve with other treatments. Specifically, studies found that six months after receiving SBRT, patients experienced an 81% drop in episodes of ventricular tachycardia (VT), a type of fast heart rhythm. This treatment works by precisely targeting the problem area in the heart with a high dose of radiation. While current results for SBRT are promising, ongoing research continues to explore its potential benefits. Participants who choose not to undergo SBRT can still receive standard medical treatment and participate in study visits and questionnaires. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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) 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04843683

StereoTactic Ablative RadioTherapy of Cardiac ... 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 ...

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

A systematic review and meta-analysis of prospective trials ... Stereotactic arrhythmia radioablation (STAR) is a noninvasive treatment of refractory ventricular tachycardia (VT).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666501825002144

Target delineation workflow and outcomes of stereotactic ... (1) Patients who survived for at least 6 months had a significant reduction (81%) in VT burden after SBRT. (2) Among those who underwent SBRT, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9117912/

Stereotactic ablative radiotherapy in patients with refractory ... The current efficacy data of SABR are limited and several prospective clinical studies are ongoing to support the use of ablative radiation dose to control VT.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1050173823001226

One-year mortality and causes of death after stereotactic ... One-year mortality in patients undergoing cardiac SBRT for refractory ventricular arrhythmias is high (∼32 %), with more than one third of these deaths ...

6. 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 ...

7. heartrhythmopen.com heartrhythmopen.com/article/S2666-5018(25)00214-4/fulltext

Target delineation workflow and outcomes of stereotactic ... (1) Patients who survived for at least 6 months had a significant reduction (81%) in VT burden after SBRT. (2) Among those who underwent SBRT, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10709113/

The state‐of‐the‐art technic of stereotactic radioablation for ... Stereotactic Arrhythmia Radioablation is recently emerging as a promising treatment for refractory VT. While early results are encouraging, careful ...