Proton Radiosurgery for the Treatment of Malignant Ventricular Tachyarrhythmias

Launched by AZIENDA PROVINCIALE PER I SERVIZI SANITARI, PROVINCIA AUTONOMA DI TRENTO · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called proton radiosurgery for patients with serious heart rhythm problems known as ventricular arrhythmias (VAs), specifically ventricular tachycardia (V-Tach). These conditions can lead to sudden cardiac death and are often managed with devices like implantable defibrillators (ICDs) or medications. However, these options may not completely prevent heart rhythm issues and can affect a patient's quality of life. The trial aims to evaluate how safe and effective proton radiosurgery is in treating these heart issues, especially for patients who have not responded well to traditional treatments.

To participate in this study, individuals must be at least 40 years old, have an ICD or similar device, and have experienced multiple episodes of V-Tach that did not respond to medications. They should also be unable to undergo standard procedures due to their heart condition or other health issues. Participants will undergo imaging tests to help identify the specific area of the heart that needs treatment and will receive proton therapy, which is a non-invasive way to deliver targeted radiation to the problem area. Throughout the study, researchers will monitor participants for any side effects and assess the treatment's effectiveness over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. age ≥ 40 years
• • 2. carrier of ICD/CRT-D or S-ICD
• 3. episodes of ventricular tachycardia/ventricular fibrillation requiring defibrillator intervention (shock or ATP) which are:
• • refractory to maximal drug therapy;
• • recurrent (at least 3 episodes in the previous 6 months);
• • 4. patients with contraindications to a conventional ablative strategy, in relation to the high risk associated with the procedure due to the severity of the heart disease and/or the presence of comorbidities or patients who have already undergone ablation, in the presence of an arrhythmogenic substrate refractory to or unsuitable for an interventional approach or patients who refuse transcatheter ablative attempts due to high intraoperative risk in relation to the patient's characteristics.
• • 5. Left ventricular ejection fraction ≥ 20%.
• Exclusion Criteria:
• • 1. inability to express informed consent
• • 2. previous thoracic radiotherapy (RT) with cardiac involvement
• • 3. active myocardial ischemia
• • 4. recent cardiac revascularization (\< 120 days)
• • 5. hemodynamic instability (cardiogenic shock, NYHA class IV)
• • 6. contraindication to radiosurgery (e.g., due to artifacts or other technical reasons)
• • 7. lack of patient cooperation in pre-procedural investigations
• • 8. ICD malfunction
• • 9. severe comorbidity with prognosis \< 12 months
• • 10. pregnancy