Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT06769451
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06769451
Study Brief:
Protocol Section:
NCT06769451