24 Participants Needed

Radiation Therapy for Ventricular Tachycardia

JR
MM
KG
Overseen ByKristen Grant, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: William Beaumont Hospitals
Must be taking: Antiarrhythmics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.13467

Who Is on the Research Team?

JR

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
See 6 more

Exclusion Criteria

I have severe heart failure.
Abandoned leads
I have had radiation therapy to my chest or upper abdomen before.
See 1 more

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?
3Treatment groups
Experimental Treatment
Group I: Radiation Therapy at 25 Gy for Ventricular TachycardiaExperimental Treatment1 Intervention
Group II: Radiation Therapy at 20 Gy for Ventricular TachycardiaExperimental Treatment1 Intervention
Group III: Radiation Therapy at 15 Gy for Ventricular TachycardiaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials
153
Recruited
113,000+

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.
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.
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.
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]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.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 ...
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 ...
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- ...
Stereotactic Arrhythmia Radiotherapy (STAR) vs Repeat ...This study demonstrates that stereotactic arrhythmia radiotherapy (STAR) has comparable efficacy to repeat catheter ablation (CA) in controlling ...
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 ...
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 ...
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 ...
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