Refractory ventricular tachycardia
Conditions
Interventions
1. In preparation for stereotactic radioablation:
- Planning-CT
- ECG-imaging.
- SF-36 and EQ5D questionnaires.
2. Stereotactic radioablation with single-fraction ablative dose of radiation.
3. F
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Structural heart disease (ischemic and non-ischemic cardiomyopathy) with myocardial scar and previous ICD implantation. • World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status grade 0-3 in the past 3 months, or grade 4 if related to the arrhythmic presentation (from fully active to capable of limited self-care). • Recurrent VT: • Despite > 1 prior catheter ablation (last in expert center) with all meaningful mapping/ablation approaches performed (endo/epicardial, LV/RV), a detailed electroanatomical map of substrate and precise image integration available. OR • In a patient that is ineligible to undergo invasive catheter ablation (e.g., LV thrombus, double mechanical valves, no vascular access) but with detailed (noninvasive) electroanatomical information and precise image integration available. • Recurrent VT should be: • Sustained monomorphic VT, compatible with the arrhythmogenic substrate. • >= 3 VT episodes (syncope, sustained VT, antitachypacing treated or ICD shock) in previous 6 months OR electrical storm (>= 3 VTs in 24 h) OR symptomatic incessant VT. • Recorded on 12-lead and compatible with the arrhythmogenic substrate. • Antiarrhythmic drugs: • Optimal medical treatment according to current ESC guidelines. • Failed, intolerance or contraindication to >= 1 antiarrhythmic drugs (amiodarone, sotalol, mexiletine, procainamide). • Patient must be able to understand and be willing to sign an Institutional Review Board (IRB)- approved written informed consent.
Exclusion criteria
Exclusion criteria: A patient that meets any of the following criteria will be excluded from participation: • Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with >=80% reduction of VT burden, i.e., any ICD-treated or highly-symptomatic VT episodes, at one year after STAR compared to the year before (including VTs during the 8 week-blanking period). Efficacy parameters will be assessed by comparing the 12 months prior to STAR with the 12 months after treatment. All arrhythmic episodes occurring during the blanking period will be collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline study parameters such as age, gender, underlying cardiac disease, LV ejection fraction, scar anatomy (3DMRI, electroanatomical map), death, (in)appropriate ICD therapy, antitachypacing, use of antiarrhythmic drugs, target dose-volume parameters, healthy tissue dose-volume parameters, toxicity, quality of life, hospitalisation, ECG-imaging (activation and repolarization times, fragmentation, activation/propagation maps) will be collected and investigated. | — |
Countries
Netherlands
Outcome results
None listed