An interventional study of 4-D navigated stereotactic radio surgical ablation in Ventricular Tachycardia, sponsored by University Hospital Ostrava. Withdrawn at 3 sites in Czechia. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment
STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).
The goal of this project is to evaluate feasibility and safety/toxicity of elimination of ventricular tachycardia (VT) associated with structural heart disease by noninvasive strategy, stereotactic radiosurgical ablation in an indication of bail-out procedure after failed catheter ablation. The arrhythmogenic substrate will be identified by imaging techniques and functionally by electroanatomic mapping and pacing. The recipients of stereotactic surgery will be patients after 2 unsuccessful catheter ablations for monomorphic VTs (one of the procedures will be performed in an expert center). The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be a critical region of the substrate defined by a combination of imaging and functional methods with an export of the merged image-electroanatomical map into the radiosurgery planning console. Primary endpoints will be a reduction of the burden of sustained VT, time to death or arrhythmic storm or appropriate therapy with implantable cardioverter-defibrillator (ICD) for isolated VT and/or time do development of radiation toxicity (both acute and late).
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
Browse Tachycardia studies →University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias will undergo 4-D navigated stereotactic radiosurgical ablation
Procedure: 4-D navigated stereotactic radio surgical ablation
4-D navigated stereotactic radio surgical ablation will be performed in patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias
Change of sustained VT burden in three 3-month intervals
Change of sustained VT burden in three 3-month intervals will be assessed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
Time frame: 50 months
Composite endpoint of (i) all-cause death, (ii) appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or (iii) sustained VT below the detection threshold
All-cause death, appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or sustained VT below the detection threshold will be observed for up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
Time frame: 50 months
3. Rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0.
The rate of acute (\<3 months) and late radiation-induced events according to CTCAE 4.0 will be observed.
Time frame: 53 months
Composite endpoint of all-cause death and appropriate ICD shock
The composite endpoint of all-cause death and appropriate ICD shock will be observed for the period of up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
Time frame: 50 months
Electric storm recurrence
The recurrence of electric storm will be observed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
Time frame: 53 months
Cardiovascular hospitalisations
The hospitalisations due to cardiovascular indications will be observed.
Time frame: 53 months
Change in quality of life
Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. 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 quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life.
Time frame: 53 months
Plan to share: Undecided — The investigators have not decided to share the individual participant data with other researchers.
This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University Hospital Ostrava