Clinical trial NCT03819504: Stereotactic Non-invasive Ablation of Ventricular Tachycardia
Official title: STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
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: 2019-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease)
* Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator)
* Prior ≥1 catheter ablation procedure for monomorphic VT
* VT recurrence early (\<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated)
* Age ≥30 years
* Signed an IRB-approved (Institutional Review Board) written informed consent

Exclusion Criteria:

* Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (\<3 months)
* Primary electrical disease (channelopathy)
* Reversible cause of VT (e.g. drug-induced, intoxications, etc)
* Pregnancy or breastfeeding
* Chronic heart failure New York Heart Association (NYHA) Class IV
* Serious comorbidities with presumed life expectancy less than one year
* Significant peripheral artery disease precluding retrograde aortic mapping
* History of chest radiotherapy

Primary outcomes:
measure: Change of sustained VT burden in three 3-month intervals
timeFrame: 50 months
measure: 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
timeFrame: 50 months
measure: 3. Rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0.
timeFrame: 53 months
Secondary outcomes:
measure: Composite endpoint of all-cause death and appropriate ICD shock
timeFrame: 50 months
measure: Electric storm recurrence
timeFrame: 53 months
measure: Cardiovascular hospitalisations
timeFrame: 53 months
measure: Change in quality of life
timeFrame: 53 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine Prague
state: Central Bohemia
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava
state: Czech Republic
city: Třinec
country: Czechia
facility: Hospital Podlesí
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Jakub Cvek, Ass.Prof.,MD,Ing.,PhD
role: STUDY_CHAIR
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