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Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Official title: Ventricular Tachycardia Ablation Through Radiation Therapy Consortium: Concept Description of an Observational Retrospective Multicentric Trial Via Matched Pair Analysis (VT-ARTr)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
149
Start Date
2025-03-30
Completion Date
2029-03-30
Last Updated
2025-05-25
Healthy Volunteers
No
Conditions
Locations (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy)
Rome, ROME, Italy