Ventricular Tachycardia (VT)
Conditions
Keywords
ventricular tachycardia, radioablation
Brief summary
Recurrent ventricular tachycardia (VT) is a potentially life-threatening arrhythmia in patients with structural heart disease. Despite the use of antiarrhythmic drugs, implantable cardioverter-defibrillators (ICDs), and radiofrequency catheter ablation, VT recurrence rates remain high-reaching up to 66% in some series. For patients with refractory VT who are not candidates for further ablation or surgical interventions, there is a significant unmet need for novel, effective, and non-invasive treatment options. Stereotactic body radiation therapy (SBRT) has recently emerged as a promising approach for treating ventricular arrhythmias through a technique known as stereotactic arrhythmia radioablation (STAR). Preliminary studies, including a phase I/II clinical trial, have demonstrated a substantial reduction in VT burden-up to 99.9%-following treatment, with an acceptable safety profile. Reported adverse events have included manageable pericardial effusion, radiation-induced pericarditis, and pneumonitis. The growing body of evidence supports STAR as a feasible and effective alternative for selected patients with treatment-resistant VT. The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy as a non-invasive ablation technique for the treatment of ventricular tachycardia (VT) in patients with refractory arrhythmias in whom conventional therapies have failed. This is a retrospective observational study aimed at comparing outcomes between patients who received stereotactic radioablation and those who did not. A matched-pair analysis will be used to adjust for baseline clinical characteristics and ensure comparability between groups.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of refractory ventricular tachycardia (VT), as previously defined * Age greater than 18 years * Presence of an implantable cardioverter-defibrillator (ICD) for follow-up * Not eligible for heart transplantation * Estimated life expectancy of at least 1 year * Ability to provide autonomous, informed consent to participate in the study
Exclusion criteria
* ICD interrogation demonstrating polymorphic VT * Patients with INTERMACS class more than 4 * Patients with LVADs * Patients with active neoplastic disease under oncological treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VT episode frequency compared to the pretreatment period | Starting from three months before treatment until 3 months later | The number of VT episodes during the 3 months prior to treatment will be compared to the number of episodes recorded during the 3-month period following the post-treatment blanking period. This comparison will help determine whether the treatment provides clinical benefits even at an early stage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in antiarrhythmic drug burden compared to the baseline | 36 months | The study aims to show whether radioablation treatment is associated with a significant reduction in the use of antiarrhythmic drugs compared to patients who did not undergo the procedure |
| Change in left ventricular end-diastolic volume compared to the baseline | 36 months | Improvement in left ventricular end-diastolic volume, as assessed through specific tests performed by a cardiologist specializing in arrhythmology, especially the Echocardiogram, and a global electrophysiological evaluation |
| Change in left ventricular end-systolic volume compared to the baseline | 36 months | Improvement in left ventricular end-systolic volume , as assessed through specific tests performed by a cardiologist specializing in arrhythmology , especially the Echocardiogram, and a global electrophysiological evaluation |
Countries
Italy
Outcome results
None listed