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:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT02919618
Eligibility Criteria:
Inclusion Criteria:
1. DOCUMENTED VT:
1. Patient must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation
\- OR-
2. Monomorphic PVCs documented on a 12-lead ECG.
2. ANTIARRHYTHMIC MEDICATION: Patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine).
-AND-
3. CATHETER ABLATION: Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure (e.g., LV thrombus, severe pulmonary disease), or have VT thought to arise from a protected location (e.g., epicardial VT with history of previous cardiac surgery).
4. MINIMUM VT BURDEN: Patient must have either:
1. At least 3 VT episodes (sustained VT, ICD ATP or ICD shock) over previous 6 months prior to enrollment -OR-
2. \>20% PVC burden with a cardiomyopathy (LVEF\<50%)
5. Patient must be deemed medically fit for stereotactic body radiation therapy by the treating physician.
6. Patient must be \> 18 years old.
7. Patient must be able to understand and be willing to sign an IRB approved written informed consent document.
\-
Exclusion Criteria:
1. Patient must not have past history of radiotherapy within the projected treatment field.
2. Advanced symptomatic heart failure as defined as NYHA Class IV heart failure (inotrope dependent and/or current left-ventricular assist device (LVAD))
3. Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm (as determined by 12-lead ECG and/or ICD interrogation).
4. More than 3 distinct clinical VT morphologies observed (ECG or ICD interrogation or invasive EP study) OR more than 5 distinct induced VT morphologies during ECGI testing.
5. Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician.
6. Unlikely to live 12 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians.
7. Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02919618
Study Brief:
Protocol Section:
NCT02919618