Phase 2
Completed N=19
Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation for Treatment of Ventricular Tachycardia
Ventricular tachycardia · Cardiomyopathy · Premature Ventricular Contractions
Source: ClinicalTrials.gov NCT02919618 ↗
Enrolled (actual)
19
Serious AEs
79.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Serious Adverse Events — 2; 0; 0; 1 Events
Summary
Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation (ENCORE) for Treatment of Ventricular Tachycardia
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Serious Adverse Events |
2; 0; 0; 1 | — |
| PRIMARY Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden |
15; 2 | — |
| SECONDARY Overall Survival |
18; 13 | — |
| SECONDARY Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment |
15; 1; 9; 1; 1; 20 | — |
| SECONDARY Health Related Quality of Life (HRQOL) |
64; 70; 87; 72; 44; 52 | — |
| SECONDARY Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden |
17 | — |
| SECONDARY Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden |
11 | — |
| SECONDARY Number of Participants With Reduction in ICD Shocks and LVEF Improvement |
13 | — |
| SECONDARY Number of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months |
16 | — |
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 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.
-
Data sourced from ClinicalTrials.gov (NCT02919618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.