Clinical trial NCT04612140: STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Official title: STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: Structural Heart Disease
Ventricular Tachycardia
Substrate Ablation
Stereotactic Radiosurgery
Functional Radiosurgery
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Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: Institute for Clinical and Experimental Medicine
name: Hospital Podlesi
First posted: 2020-11-02
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study subjects will be randomized into one of the two study arms.
Primary purpose: TREATMENT

Brief summary: A multicentre trial on clinical effects of radiosurgical ablation of ventricular tachycardia (VT).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with structural heart disease (SHD) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected)
2. Implanted implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
3. Prior ≥1 catheter ablation procedure for VT due to SHD of them the last one performed in the expert center and employed:

   3.1 all meaningful mapping/ablation approaches (endocardial/epicardial access to left / right ventricular substrate as possible or appropriate) 3.2 precise electroanatomical mapping of the arrhythmogenic substrate in anticipation of future radiosurgery 3.3 additional mapping of structures used for precise image integration (aortic arch, left main ostium, right ventricular endocardial surface)
4. VT recurrence after the last catheter ablation fulfilling all criteria as follows:

   4.1 clinically relevant and requiring further intervention 4.2 compatible with the previously characterized arrhythmogenic substrate 4.3 occurred on stable antiarrhythmic medication (mostly amiodarone) unless contraindicated 4.4 reversible cause excluded
5. Signed an Institutional Review Board (IRB)-approved written informed consent

Exclusion Criteria:

1. Age \< 20 years
2. Acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (\< 3 months)
3. Primary electrical disease (channelopathy)
4. Pregnancy or breastfeeding
5. Chronic heart failure with New York Heart Association (NYHA) Class IV
6. Serious comorbidities with presumed life expectancy less than one year
7. Significant peripheral artery disease precluding retrograde aortic mapping

Primary outcomes:
measure: Recurrence of sustained VT after 3-month blanking period
timeFrame: 3 months
Secondary outcomes:
measure: VT burden according to implantable device
timeFrame: 3 months
measure: Non-inducibility of VT at 6 months
timeFrame: 6 months
measure: Recurrence of sustained VT excluding antitachycardia-pacing (ATP)-treated episodes
timeFrame: 24 months
measure: Electric storm recurrence
timeFrame: 24 months
measure: Cardiovascular hospitalization
timeFrame: 24 months
measure: All-cause death
timeFrame: 24 months
measure: Change in quality of life: EQ-5D
timeFrame: 24 months
measure: Change in echocardiographic indices
timeFrame: 24 months
measure: Rate of major procedure-related complications (control arm)
timeFrame: 24 months
measure: Rate of acute post-radiation complications (intervention arm)
timeFrame: 24 months
measure: Extent of scar
timeFrame: 6 months
measure: Rate of late radiation-induced events
timeFrame: 24 months
measure: Radiation dose
timeFrame: 24 months
measure: Need of antiemetic drugs
timeFrame: 24 months
measure: Dynamics of serum troponin level
timeFrame: 24 months
Other outcomes:
Locations:
city: Třinec
country: Czechia
facility: Hospital Podlesí
state: Moravian-Silesian Region
city: Praha
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
affiliation: University Hospital Ostrava
name: Jakub Cvek, Ass.Prof.,MD,Ing, PhD,MBA
role: PRINCIPAL_INVESTIGATOR
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