Radiation Therapy for Ventricular Tachycardia

Overseen By Kristen Grant, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Must be taking: Antiarrhythmics

Disqualifiers: Class IV heart failure, others

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

Compensation: Varies

Number of Visits: 4

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating ventricular tachycardia (VT), a heart condition that causes dangerously fast heartbeats. Researchers aim to determine the lowest safe dose of radiation therapy (cardiac radioablation) needed to treat VT effectively. Participants will receive varying radiation doses to identify the most effective one. Individuals who have had a heart attack, experience frequent VT episodes despite medication, and have tried other treatments might be suitable candidates. As an unphased trial, this study provides an opportunity to contribute to groundbreaking research that could lead to new treatment options for VT.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves participants with ventricular tachycardia that is not controlled by medications, it is likely that you will continue your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cardiac radioablation, a type of radiation therapy, is generally well-tolerated for treating ventricular tachycardia (VT), a serious heart rhythm problem. One study found that patients experienced fewer VT episodes after this treatment, effectively reducing the occurrence of this dangerous heart rhythm.

Regarding safety, several large studies have confirmed that stereotactic radiation therapy, a precise form of radiation treatment, is safe for patients with recurring VT. These studies indicate that patients usually do not experience severe side effects from the treatment.

While there is no absolute guarantee of zero side effects, these findings are promising. They suggest that cardiac radioablation is a safe option for those dealing with hard-to-treat VT. A thorough discussion with a healthcare provider is essential to understand the potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cardiac radioablation for ventricular tachycardia because it offers a non-invasive alternative to the standard of care treatments like antiarrhythmic drugs and catheter ablation. Unlike these traditional methods, which can involve surgery or long-term medication use, cardiac radioablation uses targeted radiation therapy, which can be precisely delivered to the heart tissue causing the arrhythmia. This innovative approach has the potential to reduce procedural risks and recovery time. Additionally, different radiation doses—15 Gy, 20 Gy, and 25 Gy—are being explored to determine the most effective and safe option, which could lead to personalized treatment plans.

What evidence suggests that this trial's treatments could be effective for ventricular tachycardia?

Research has shown that cardiac radioablation is a promising treatment for ventricular tachycardia (VT), especially for patients unresponsive to other treatments. This trial will compare different doses of radiation therapy—15 Gy, 20 Gy, and 25 Gy—to evaluate their effectiveness and safety. One study found that this approach can greatly reduce VT episodes. Another analysis showed that this method has moderate side effects and is reasonably safe. Specifically, a key trial found that radiation therapy effectively decreased the number of VT episodes and the need for medication. Overall, cardiac radioablation offers a potential new option for those dealing with severe heart rhythm problems. ^{1 3 4 6 7}

Who Is on the Research Team?

John M. Robertson

Principal Investigator

Corewell Health William Beaumont University Hospital

Are You a Good Fit for This Trial?

This trial is for adults who've had a heart attack and suffer from ventricular tachycardia (VT), which hasn't improved after at least one cardiac ablation. They must have an implanted defibrillator, not be pregnant or breastfeeding if of reproductive age, and should not have severe heart failure or prior chest radiation.

Inclusion Criteria

I have had a procedure to correct heart rhythm problems.

I can safely undergo a Cardiac MRI according to standard cardiology guidelines.

Automatic implanted cardiac defibrillator present

Exclusion Criteria

I have severe heart failure.

Abandoned leads

I have had radiation therapy to my chest or upper abdomen before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Radiation Therapy

Participants receive cardiac radioablation with varying doses (15 Gy, 20 Gy, or 25 Gy) to determine the minimum effective dose

1 day

1 visit (in-person)

Observation and Evaluation

Participants are observed for dose limiting toxicity and efficacy, with a 6-week blanking period followed by 8 weeks of evaluation

14 weeks

Regular monitoring (in-person and remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Radioablation

Trial Overview

The study tests the lowest effective dose of Stereotactic Body Radiation Therapy (SBRT) to treat VT that's resistant to other treatments. It also examines how well Delayed Enhancement Cardiac MRI helps in targeting the therapy area.

How Is the Trial Designed?

Group I: Radiation Therapy at 25 Gy for Ventricular Tachycardia Experimental Treatment 1 Intervention

Post myocardial infarction patients with refractory ventricular tachycardia requiring cardio ablation, treated with 25 Gy

Group II: Radiation Therapy at 20 Gy for Ventricular Tachycardia Experimental Treatment 1 Intervention

Post myocardial infarction patients with refractory ventricular tachycardia requiring cardio ablation, treated with 20 Gy

Group III: Radiation Therapy at 15 Gy for Ventricular Tachycardia Experimental Treatment 1 Intervention

Post myocardial infarction patients with refractory ventricular tachycardia requiring cardio ablation, treated with 15 Gy

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Corewell Health East

Lead Sponsor

Published Research Related to This Trial

In a prospective trial involving 11 patients with recurrent ventricular tachycardia (VT), stereotactic arrhythmia radioablation (STAR) demonstrated a safety profile with only one patient experiencing a significant treatment-related adverse event, indicating it is a relatively safe option for this condition.

STAR resulted in an 84.3% reduction in VT burden among evaluable patients, suggesting it is an effective treatment for selected patients with VT, although many experienced recurrence and further interventions were needed, highlighting the need for long-term outcome studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. Miszczyk, M., Sajdok, M., Bednarek, J., et al.[2023]

In a study involving 20 domestic swine, noninvasive cardiac ablation using proton beam radiation showed dose-dependent adverse effects on left ventricular (LV) function, with significant declines in ejection fraction and increases in LV volume observed about 3 months post-treatment.

The study found that higher radiation doses correlated with greater declines in LV function, emphasizing the importance of precise targeting and energy delivery in noninvasive ablation procedures to minimize potential harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left ventricular function after noninvasive cardiac ablation using proton beam therapy in a porcine model. Hohmann, S., Deisher, AJ., Suzuki, A., et al.[2020]

Cardiac radioablation is a promising treatment for patients with therapy-refractory ventricular tachycardia (VT) who cannot undergo catheter ablation, but it requires precise definition of the clinical target volume (CTV) based on electroanatomical mapping (EAM).

A study involving data from three cases across five university centers revealed significant variability in CTV definitions, highlighting the need for standardized protocols to ensure consistency in multicenter clinical trials like the RAVENTA trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary Clinical Target Volume Generation for Cardiac Radioablation: Multicenter Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. Boda-Heggemann, J., Blanck, O., Mehrhof, F., et al.[2021]

Radioablation has shown promising results in reducing ventricular arrhythmias, with over 85% reduction in arrhythmia episodes in patients and significant electrophysiological improvements in animal studies, including a 75% reduction in ventricular arrhythmia inducibility.

Despite these encouraging outcomes, the overall evidence for the efficacy and safety of radioablation is limited, highlighting the need for further research to better understand its long-term effects and optimal application in therapy-refractory patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac radioablation-A systematic review. van der Ree, MH., Blanck, O., Limpens, J., et al.[2021]

A 76-year-old male patient with life-threatening ventricular arrhythmia underwent stereotactic cardiac radioablation after unsuccessful catheter ablation, receiving a total of 24 Gray in three fractions around the apical aneurysm.

The radioablation provided an immediate antiarrhythmic effect that lasted for at least 6 months without significant radiation-related side effects, suggesting it could be a viable rescue therapy for refractory ventricular tachycardia and ventricular fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Cardiac Radiation to Control Ventricular Tachycardia and Fibrillation Storm in a Patient with Apical Hypertrophic Cardiomyopathy at Burnout Stage: Case Report. Park, JS., Choi, Y.[2021]

Cardiac radioablation is a promising new treatment for recurrent ventricular tachycardias, especially in patients with structural heart disease, where traditional methods have limited success.

There is a significant knowledge gap between cardiology and radiation oncology, highlighting the need for collaboration to optimize the use of radiation in treating heart conditions and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rapidly-Developing Area of Radiocardiology: Principles, Complications and Applications of Radiotherapy on the Heart. Aguilar, M., Qian, PC., Boeck, M., et al.[2022]

In a prospective trial involving 19 patients with treatment-refractory ventricular tachycardia (VT) or PVC-related cardiomyopathy, noninvasive cardiac radioablation significantly reduced the median number of VT episodes from 119 to just 3, demonstrating high efficacy in managing arrhythmias.

The procedure had a modest safety profile, with only 10.5% of patients experiencing serious treatment-related adverse events, and it led to a significant decrease in the use of antiarrhythmic medications from 59% to 12%, along with improvements in quality of life for many patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Robinson, CG., Samson, PP., Moore, KMS., et al.[2020]

Cardiac radioablation is a promising treatment for patients with refractory ventricular tachycardia, showing feasibility across different treatment planning systems, including robotic arm and C-arm LINACs, with comparable plan quality.

Significant variability in dose distribution was observed among treatment plans, highlighting the need for standardized guidelines to optimize treatment outcomes, particularly concerning cardiac substructures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Planning for Cardiac Radioablation: Multicenter Multiplatform Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. Kluge, A., Ehrbar, S., Grehn, M., et al.[2022]

In a study of 6 patients treated with noninvasive cardiac radioablation for ventricular tachycardia (VT), there was a significant reduction in the burden of ventricular beats, with a 49% decrease within 24 hours and a 70% decrease at 1 month post-treatment.

Long-term follow-up showed that 5 out of 6 patients experienced complete or partial remission of their ventricular arrhythmias, indicating that cardiac radioablation is both effective and safe for managing intractable VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term and long-term effects of noninvasive cardiac radioablation for ventricular tachycardia: A single-center case series. Chang, WI., Jo, HH., Cha, MJ., et al.[2023]

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.

heartrhythmjournal.com

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

A systematic review and meta-analysis of prospective trials ...

In conclusion, STAR is a promising treatment method, characterized by moderate toxicity. We observed 1-year mortality of ≈27% in this population ...

3.

astro.org

astro.org/news-and-publications/news-and-media-center/news-releases/2025/radiation-therapy-shows-promise-for-patients-with-severe-heart-rhythm-disorder

Radiation therapy shows promise for patients with severe ...

In the landmark ENCORE-VT trial previously published by the Washington University team, cardiac radiation reduced VT episodes and anti- ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0360301625062236

Stereotactic Arrhythmia Radiotherapy (STAR) vs Repeat ...

This study demonstrates that stereotactic arrhythmia radiotherapy (STAR) has comparable efficacy to repeat catheter ablation (CA) in controlling ...

5.

redjournal.org

redjournal.org/article/S0360-3016(25)06223-6/fulltext

Stereotactic Arrhythmia Radiation Therapy Versus Repeat ...

However, no studies have directly compared the 2 modalities. This study reports 3-year safety and efficacy outcomes for STAR versus CA in ...

6.

sciencedirect.com

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

One-year outcomes after stereotactic body radiotherapy for ...

There were significant reductions in treated VT at 6 weeks to 6 months (98%) and at 12 months (99%) compared to the 6 months before treatment. There was a ...

7.

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 ...