Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation for Treatment of Ventricular Tachycardia (ENCORE-VT)
Ventricular Tachycardia, Cardiomyopathy, Premature Ventricular Contractions
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ventricular Tachycardia, Ablation, Noninvasive
Eligibility Criteria
Inclusion Criteria:
DOCUMENTED VT:
Patient must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation
- OR-
- Monomorphic PVCs documented on a 12-lead ECG.
ANTIARRHYTHMIC MEDICATION: Patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine).
-AND-
- 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).
MINIMUM VT BURDEN: Patient must have either:
- At least 3 VT episodes (sustained VT, ICD ATP or ICD shock) over previous 6 months prior to enrollment -OR-
- >20% PVC burden with a cardiomyopathy (LVEF<50%)
- Patient must be deemed medically fit for stereotactic body radiation therapy by the treating physician.
- Patient must be > 18 years old.
Patient must be able to understand and be willing to sign an IRB approved written informed consent document.
-
Exclusion Criteria:
- Patient must not have past history of radiotherapy within the projected treatment field.
- Advanced symptomatic heart failure as defined as NYHA Class IV heart failure (inotrope dependent and/or current left-ventricular assist device (LVAD))
- Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm (as determined by 12-lead ECG and/or ICD interrogation).
- 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.
- Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician.
- Unlikely to live 12 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians.
Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.
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Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Experimental
stereotactic body radiotherapy (SBRT)
Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.