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

Trial Summary

What is the purpose of this trial?

The goal of this interventional study is to determine the minimum dose necessary for successful cardiac radioablation of refractory ventricular tachycardia (VT) and to study the utility of target volume definition using Delayed Enhancement Cardiac MRI (DE-CMR) .

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.

What data supports the effectiveness of the treatment Cardiac Radioablation for Ventricular Tachycardia?

Research shows that cardiac radioablation can significantly reduce episodes of ventricular tachycardia (a type of fast heart rhythm) by more than 85% in patients who do not respond to other treatments, with a good short-term safety profile. ^{1 2 3 4 5}

Is cardiac radioablation safe for treating ventricular tachycardia?

Cardiac radioablation, also known as stereotactic arrhythmia radioablation (STAR), has been reported to be generally safe for treating ventricular tachycardia, with studies showing promising short-term safety profiles. However, more research is needed to fully understand its long-term safety and effects on the heart. ^{1 3 5 6 7}

How is cardiac radioablation treatment different from other treatments for ventricular tachycardia?

Cardiac radioablation is a unique, noninvasive treatment for ventricular tachycardia that uses targeted radiation to modify heart tissue, unlike traditional catheter ablation which requires inserting a tube into the heart. This method is particularly useful for patients who cannot undergo catheter ablation and has shown effectiveness in controlling arrhythmias without significant side effects. ^{1 2 5 8 9}

Research Team

John M. Robertson

Principal Investigator

Corewell Health William Beaumont University Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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 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]

References

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

Treatment Planning for Cardiac Radioablation: Multicenter Multiplatform Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. [2022]

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

Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. [2020]

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

Cardiac radioablation-A systematic review. [2021]

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

Left ventricular function after noninvasive cardiac ablation using proton beam therapy in a porcine model. [2020]

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

Short-term and long-term effects of noninvasive cardiac radioablation for ventricular tachycardia: A single-center case series. [2023]

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

Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The Rapidly-Developing Area of Radiocardiology: Principles, Complications and Applications of Radiotherapy on the Heart. [2022]

8. Korea (South) 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. [2021]

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

Interdisciplinary Clinical Target Volume Generation for Cardiac Radioablation: Multicenter Benchmarking for the RAdiosurgery for VENtricular TAchycardia (RAVENTA) Trial. [2021]