Non-invasive Ablation of Ventricular Tachycardia

University Hospital Ostrava

Status: Completed

Conditions: Ventricular Tachycardia

Treatments: Procedure: 4-D navigated stereotactic radiosurgical ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03601832

NIRA-VT

18/RVO-FNOs/2018 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

4-D navigated stereotactic radiosurgical ablation

Experimental group

Description:

The patients enroled to this arm of the study will undergo 4-D navigated stereotactic radiosurgical ablation.

Treatment:

Procedure: 4-D navigated stereotactic radiosurgical ablation