A multicentre trial on clinical effects of radiosurgical ablation of ventricular tachycardia (VT).
Patients with previously failed conventional RF catheter ablation will be randomized to radiosurgery (active treatment group) or repeated catheter ablation (control treatment group). Details on inclusion and exclusion criteria are provided below. Randomization Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of structural heart disease (SHD), left ventricular (LV) ejection fraction, and serum B-type natriuretic peptide (NT-proBNP) level.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
The study subjects randomized in this study arm will undergo a radiosurgery procedure.
The study subjects randomized in this study arm will undergo repeated catheter ablation.
Hospital Podlesí
Třinec, Moravian-Silesian Region, Czechia
Institute for Clinical and Experimental Medicine
Prague, Czechia
Recurrence of sustained VT after 3-month blanking period
Recurrence of sustained VT after 3-month blanking period will be assessed.
Time frame: 3 months
VT burden according to implantable device
Number of sustained VT burden in three 3-month intervals after radiosurgery will be assessed.
Time frame: 3 months
Non-inducibility of VT at 6 months
TRUE/FALSE - Pacing protocol will be using 2 basic cycle length drives (600 and 400 ms) and 1-3 extrastimuli with coupling intervals decremented by 10 ms up to the refractoriness or 200 ms.
Time frame: 6 months
Recurrence of sustained VT excluding antitachycardia-pacing (ATP)-treated episodes
Recurrence of sustained VT excluding ATP-treated episodes will be assessed.
Time frame: 24 months
Electric storm recurrence
The recurrence of electric storm will be observed.
Time frame: 24 months
Cardiovascular hospitalization
The number of hospitalisations due to cardiovascular indications will be observed.
Time frame: 24 months
All-cause death
The all-cause death will be observed.
Time frame: 24 months
Change in quality of life: EQ-5D
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.
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Time frame: 24 months
Change in echocardiographic indices
Left vetricle ejection fraction (%) will be observed.
Time frame: 24 months
Rate of major procedure-related complications (control arm)
The rate of major procedure-related complications will be observed among the study subjects enrolled to the control arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
Time frame: 24 months
Rate of acute post-radiation complications (intervention arm)
The rate of acute post-radiation complications will be observed among the study subjects enrolled to the intervention arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Time frame: 24 months
Extent of scar
The extent of scar will be assessed 6 months after radiosurgery, based on invasive electroanatomical mapping.
Time frame: 6 months
Rate of late radiation-induced events
The rate of late radiation-induced events will be assessed according to CTCAE 5.0 in each cohort of isodose line level, specifically, rate of radiation myocarditis, pericarditis, and pneumonitis.
Time frame: 24 months
Radiation dose
The radiation dose will be observed for each interventional procedure, CT imaging and radiosurgery, together with the cumulative dose.
Time frame: 24 months
Need of antiemetic drugs
The need of antiemetic drugs will be assessed in all study subjects.
Time frame: 24 months
Dynamics of serum troponin level
The dynamics of serum troponin level will be observed in all study subjects.
Time frame: 24 months