PROspective feasibility study of STereotactic Arrhythmia Radioablatio
- Conditions
- Ventriculair tachycardia
- Registration Number
- NL-OMON24469
- Lead Sponsor
- niversitair medisch centrum Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 11
1.Patient must be >18 years old
2.Patient must have therapy refractory VT.
Patient must have failed or become intolerant to at least one antiarrhythmic medication and one invasive catheter ablation procedure or invasive catheter ablation is not possible due to a contraindication (e.g. unfit for general anaesthesia, severe pulmonary disease).
3. Cardiomyopathy, Ischemic or non-ischemic.
4. Patients must have transvenous ICD
5. Patients must have ICD information before study treatment
1.Prior radiotherapy treatment above 30 Gy of the current treatment region
2.Patients must not be pregnant or lactating
3.NYHA class 4
4.Extreme arrhythmia substrate:
a.Polymorphic VT/VF
b.>3 distinct clinical VT morphologies
c.>5 distinct induced VT morphologies during testing
5.The radiotherapy target volume must be suitable for stereotactic radiation.
6.MRI criteria:
a.claustrophobia
b.non-MRI compatible according to https://richtlijn.mijnumc.nl/Beeld/MRI/Documents/Vragenlijst%20MRI-onderzoek%20volwassenen.pdf
7.GFR above 30 ml/min
8.Within one year after heart surgery or placing of an artificial heart valve
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate acute safety of delivering STAR. Side effects possibly, probably or definitely related to study treatment are registered conform CTCAE v5.0. The incidence of grade 3 and above toxicity should be = 33.33% within 90 days of treatment.
- Secondary Outcome Measures
Name Time Method •Reduction in VT burden defined by decline in ICD therapy in shocks and/or ATP compared to the 6 months period prior to STAR (or shorter if ICD information is lacking), <br>•Changes in antiarrhythmic medication due to treatment effects.<br>•Changes in patient reported quality of life (recorded as EQ 5D 5L).<br>•Report late toxicity after 90-days post intervention (according to CTCAE v5.0)<br>