An interventional study of 4-D navigated stereotactic radiosurgical ablation in Ventricular Tachycardia, sponsored by University Hospital Ostrava. Completed at 3 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment
Phase I/II study of 4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia (NIRA-VT).
The goal of this project dealing with 4D-navigated substrate ablation is to evaluate the feasibility and safety of elimination of the scar-related monomorphic ventricular tachycardia (VT) or tachycardias by stereotactic radiosurgical ablation that is completely non-invasive. The arrhythmic substrate is defined as the scar after myocardial infarction (MI) described by transthoracic echocardiography (TTE) and specified by PET-CT or MRI. All sustained monomorphic VT induced by programmed ventricular stimulation via implanted ICD (Implantable Cardioverter Defibrillator) will be analyzed using body surface ECG mapping. The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be based on accordance between a post-infarction scar (PET-CT or MRI imaging) and arrhythmic substrate (body surface ECG mapping).
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's enrollment of 10 is below the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients enroled to this arm of the study will undergo 4-D navigated stereotactic radiosurgical ablation.
Procedure: 4-D navigated stereotactic radiosurgical ablation
4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia in patients with sustained monomorphic ventricular tachycardia/tachycardias after myocardial infarction.
Composite of death
Composite of death occurring at any time after treatment or arrhythmic storm (three or more documented episodes of VT within 24 hours) or appropriate ICD therapy (both shock and pacing) after a 90-day treatment period. 90-day treatment period was imposed to exclude nonfatal outcomes that might occur during acute radiation reaction. Moreover, functional radiosurgery has 90% success rate after 3 months.
Time frame: 90 days
Acute radiation-induced events
Acute radiation-induced events (within 3 months after treatment) according to CTCAE 4.0. Major concern will be on radiation myocarditis, pericarditis and pneumonitis/fibrosis. Needs of antiemetic drugs will be recorded.
Time frame: 18 months
Late radiation-induced effects
Late radiation-induced effects (after 3 months after treatment) according to CTCAE 4.0. Major concern will be on radiation myocarditis, pericarditis and pneumonitis/fibrosis. Needs of antiemetic drugs will be recorded.
Time frame: 18 months
Time to death at any time
Time frame: 18 months
Time to arrhythmic storm
Time to arrhythmic storm (three or more documented episodes of VT within 24 hours) at any time and after 90-day treatment period.
Time frame: 90 days
Time to appropriate ICD shock
Time to appropriate ICD shock at any time and after 90-day treatment period.
Time frame: 90 days
Time to appropriate antitachycardial pacing by ICD
Time to appropriate antitachycardial pacing by ICD at any time and after 90-day treatment period.
Time frame: 90 days
Hospitalization due to VT
Time frame: 18 months
Hospitalization due to chronic heart failure
Time frame: 18 months
Quality of life measured with EQ-5D questionnaire
Quality of life measurement using a standardised tool named EQ-5D. EQ-5D is a standardised instrument in the form of a questionnaire developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D instrument consists of a descriptive system and the EuroQol-visual analogue scales (EQ VAS). The quality of life is measured in 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The higher the score achieved, the higher the quality of life of the patient.
Time frame: 18 months
Plan to share: Undecided
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Ostrava