Stereotactic Radioablation for Ventricular Tachycardia
(START-VT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with ventricular tachycardia (VT), a serious heart rhythm issue often associated with scarred heart tissue. The treatment, Stereotactic Arrhythmia Radioablation (STAR), uses precise radiation to target and repair the scarred areas causing the abnormal rhythm. Researchers aim to determine if STAR can safely and effectively prevent VT episodes without the side effects of current treatments. Individuals with a history of VT and heart damage visible on scans, especially those still experiencing symptoms or shocks from their defibrillator, might be suitable candidates for this study. Participants will undergo monitoring for a year to evaluate the treatment's effectiveness and check for any side effects. As an unphased trial, this study provides a unique 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 information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that this technique is safe for treating ventricular tachycardia?
Research has shown that Stereotactic Arrhythmia Radioablation (STAR) is generally safe and well-tolerated for people with ventricular tachycardia (VT), a type of fast heart rhythm. Studies have found that STAR can significantly reduce episodes of VT, with one study noting an 87% decrease in these episodes. Importantly, there was no significant drop in heart or lung function, indicating the treatment does not harm these areas.
Another study found that STAR is safe in the short term, with no major heart-related side effects. STAR offers similar results to catheter ablation, a more traditional treatment, but has the advantage of being non-invasive, meaning it doesn't involve surgery and carries less risk.
Overall, the evidence suggests that STAR is a promising and safe option for managing VT, especially for those who cannot undergo more invasive treatments.12345Why are researchers excited about this trial?
Unlike traditional treatments for ventricular tachycardia that often involve catheter ablation or medication, stereotactic arrhythmia radioablation (STAR) offers a non-invasive alternative by using targeted radiotherapy. This method, similar to treatments used in cancer therapy, precisely delivers radiation to the area of the heart causing the arrhythmia. Researchers are excited about STAR because it has the potential to reduce recovery time and minimize the risks associated with invasive procedures, all while maintaining high precision in targeting the problematic heart tissue. This innovative approach could eventually transform how ventricular tachycardia is treated, providing a safer and more efficient option for patients.
What evidence suggests that Stereotactic Arrhythmia Radioablation is effective for ventricular tachycardia?
Studies have shown promising results for Stereotactic Arrhythmia Radioablation (STAR) in treating ventricular tachycardia (VT), a condition characterized by an excessively fast heartbeat. Previous research demonstrated that STAR reduced VT episodes by about 81.5% and shocks from an implantable heart device by about 84.7%. Another study found a 99.9% reduction in VT episodes just six weeks after treatment. STAR is a non-invasive treatment targeting the heart's scar tissue responsible for the abnormal rhythm. While some studies suggest it may not always be effective long-term for everyone, many patients have experienced significant improvements. This trial will evaluate STAR as a promising option for those dealing with VT.46789
Are You a Good Fit for This Trial?
This trial is for adults with structural heart disease who have ongoing episodes of a specific type of fast, abnormal heart rhythm (monomorphic ventricular tachycardia). Participants should not have had prior ablation procedures and must be able to undergo imaging and follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single 25 Gy fraction of stereotactic body radiotherapy targeted at the arrhythmogenic substrate
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 6 weeks, 3, 6, 9, and 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Stereotactic Arrhythmia Radioablation
Trial Overview
The study tests stereotactic arrhythmia radioablation (STAR), a non-invasive treatment that uses targeted radiation to treat the scar tissue in the heart causing abnormal rhythms. All participants receive one session of STAR and are monitored over 12 months for safety and effectiveness.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Single 25 Gy fraction of VMAT-based stereotactic body radiotherapy delivered to the arrhythmogenic substrate identified by cardiac CT, 12-lead ECG of the clinical arrhythmia, and (where available) non-invasive electrocardiographic mapping or electroanatomical mapping. In selected cases with large planning target volumes or proximity to organs at risk, the dose may be delivered in 2 fractions 24-48 hours apart. Participants are followed for 12 months for arrhythmia outcomes and radiation toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Southlake Health
Lead Sponsor
Citations
Stereotactic Arrhythmia Radiation Therapy Versus Repeat ...
Twelve patients died within 3 years of STAR; 75% (N = 9) were unrelated to VT, and none were from treatment-related SAE. There was no statistically significant ...
A systematic review and meta-analysis of prospective trials ...
Data from prospective trials on stereotactic arrhythmia radioablation (STAR) for ventricular tachycardia (VT), also known as cardiac ...
Stereotactic Arrhythmia Radioablation for Refractory ... - PMC
Summary of Pooled-Analysis Results for Stereotactic Arrhythmia Radioablation (STAR) in Ventricular Tachycardia (VT): Outcomes include pooled ...
4.
frontiersin.org
frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.870001/fullSafety and Efficacy of Stereotactic Arrhythmia ...
The procedure was highly effective, with a 99.9% reduction of the burden of VT after the first 6 weeks after stereotactic radioablation (blanking period) as ...
Stereotactic Arrhythmia Radiotherapy (STAR) vs. Repeat ...
We hypothesize that STAR offers comparable VT control with potential for improved early safety outcomes given its noninvasive approach. This study reports on 3- ...
Stereotactic arrhythmia radioablation (STAR)
We observed 1-year mortality of ≈27% in this population of critically ill patients suffering from refractory VT. Most patients experience a significant ...
Stereotactic Arrhythmia Radiation Therapy Versus Repeat ...
Stereotactic Arrhythmia Radiation Therapy Versus Repeat Catheter Ablation for Refractory Ventricular Tachycardia: 3-Year Safety and Efficacy Outcomes.
Stereotactic arrhythmia radioablation for ventricular tachycardia
Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial.
radiosurgery in treatment of ventricular tachycardia ...
STAR appears to be a safe and effective treatment modality. The short-term safety profile is favourable, and no clinically relevant cardiac ...
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