Clinical trial NCT03601832: Non-invasive Ablation of Ventricular Tachycardia
Official title: Phase I/II Study of 4-D Navigated Non-invasive Radiosurgical Ablation of Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: scar-related
ventricular tachycardia
substrate ablation
stereotactic radiosurgery
functional radiosurgery
4D navigation
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University of Ostrava
name: Hospital Podlesi
name: Hospital Nový Jičín
First posted: 2018-07-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients enroled in the study are allocated to one group with 4-D navigated stereotactic radiosurgical ablation.
Primary purpose: TREATMENT

Brief summary: Phase I/II study of 4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia (NIRA-VT).

Detailed description: The goal of this project dealing with 4D-navigated substrate ablation is to evaluate the feasibility and safety of elimination of the scar-related monomorphic ventricular tachycardia (VT) or tachycardias by stereotactic radiosurgical ablation that is completely non-invasive. The arrhythmic substrate is defined as the scar after myocardial infarction (MI) described by transthoracic echocardiography (TTE) and specified by PET-CT or MRI. All sustained monomorphic VT induced by programmed ventricular stimulation via implanted ICD (Implantable Cardioverter Defibrillator) will be analyzed using body surface ECG mapping. The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be based on accordance between a post-infarction scar (PET-CT or MRI imaging) and arrhythmic substrate (body surface ECG mapping).

Eligibility criteria: Inclusion Criteria:

* history of sustained monomorphic VT or termination of monomorphic VT by ICD (appropriate therapy) during previous 6 months prior to enrollment
* implantation ICD
* inducibility at least one of monomorphic ventricular tachycardia by ICD during EP study with programmed ventricular stimulation
* history of myocardial infarction (MI)
* left ventricular scar and decreased systolic function of the left ventricle (ejection fraction of left ventricle less than 40%) based on transthoracic ultrasound
* stable chronic heart failure (NYHA II-III)
* older than 18 years
* signed an IRB approved written informed consent document.
* failed at least one invasive catheter ablation procedure or have a contraindication to a catheter ablation procedure

Exclusion Criteria:

* acute myocardial infarction
* chronic heart failure NYHA IV
* channelopathy
* reversible cause of VT (e.g. ionic dysbalance, intoxications)
* pregnancy or breastfeeding
* history of chest radiotherapy
* arrhythmic substrate larger than 100 ccm

Primary outcomes:
measure: Composite of death
timeFrame: 90 days
measure: Acute radiation-induced events
timeFrame: 18 months
measure: Late radiation-induced effects
timeFrame: 18 months
Secondary outcomes:
measure: Time to death at any time
timeFrame: 18 months
measure: Time to arrhythmic storm
timeFrame: 90 days
measure: Time to appropriate ICD shock
timeFrame: 90 days
measure: Time to appropriate antitachycardial pacing by ICD
timeFrame: 90 days
measure: Hospitalization due to VT
timeFrame: 18 months
measure: Hospitalization due to chronic heart failure
timeFrame: 18 months
measure: Quality of life measured with EQ-5D questionnaire
timeFrame: 18 months
Other outcomes:
Locations:
city: Nový Jičín
country: Czechia
facility: Hospital Nový Jičín, Nuclear Medicine - PET/CT
state: Moravian-Silesian Region
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
city: Třinec
country: Czechia
facility: Hospital Podlesí
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Jakub Cvek, Ing.,MD,Ph.D.
role: PRINCIPAL_INVESTIGATOR
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