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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT06411392
Eligibility Criteria:
Inclusion Criteria:
* Recurrent VTs/VES with significant burden despite guideline-directed therapy
* Existing protective ICD (Implantable cardioverter-defibrillator) implantation except in the presence of contraindications
* AND lack of response or intolerance to antiarrhythmic medication
* AND status post ≥1 catheter ablation due to monomorphic VT(s) and VT early recurrence (\<12 months after the last catheter ablation) OR contraindication for endocardial ablation (mechanical valve prosthesis, LV (left ventricular) thrombus, or lack of vascular access in suspicion of endocardial substrate)
* MINIMAL VT BURDEN: The patient must have had at least 3 VT episodes (sustained VT, ICD-ATP, or ICD shock) in the last 3 months prior to study enrollment.
* Presence of suitability for radiation therapy with respect to SBRT
* Age ≥ 18 years
* Existing informed consent
Exclusion Criteria:
* Acute myocardial infarction or percutaneous coronary intervention or heart surgery (\<3 months before study enrollment)
* Status post intra-thoracic pre-radiation
* Immediate proximity to radiosensitive structures (e.g., esophagus) making therapy unsafe to administer
* Advanced symptomatic heart failure (NYHA Class IV)
* Polymorphic VT or ventricular fibrillation (confirmed in 12-lead ECG and/or ICD interrogation)
* Extensive myocardial scar substrate that would result in too large of a radiation volume
* Life expectancy \< 6 months considering all comorbidities and in the Seattle Heart Failure Model
* Presence of a Left Ventricular Assist Device (LVAD)
* Use of cytotoxic medications
* Pregnancy or lactation - negative pregnancy test within 14 days before study entry required for women of childbearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06411392
Study Brief:
Protocol Section:
NCT06411392