Stereotactic Non-invasive Ablation of Ventricular Tachycardia

N/AWithdrawnNCT03819504

University Hospital Ostrava

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Ventricular Tachycardia

Interventions

4-D navigated stereotactic radio surgical ablationPROCEDURE

4-D navigated stereotactic radio surgical ablation will be performed in patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (3)

Institute for Clinical and Experimental Medicine Prague

Prague, Central Bohemia, Czechia

University Hospital Ostrava

Ostrava-Poruba, Czech Republic, Czechia

Hospital Podlesí

Třinec, Moravian-Silesian Region, Czechia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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