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Completed

NCT Number: NCT03601832

Non-invasive Ablation of Ventricular Tachycardia

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

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Nový Jičín, Nuclear Medicine - PET/CT, Nový Jičín, Moravian-Silesian Region, Czechia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4-D navigated stereotactic radiosurgical ablation

Procedure

4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia in patients with sustained monomorphic ventricular tachycardia/tachycardias after myocardial infarction.

Primary outcomes

  1. Composite of death

    Time frame: 90 days

    Composite of death occurring at any time after treatment or arrhythmic storm (three or more documented episodes of VT within 24 hours) or appropriate ICD therapy (both shock and pacing) after a 90-day treatment period. 90-day treatment period was imposed to exclude nonfatal outcomes that might occur during acute radiation reaction. Moreover, functional radiosurgery has 90% success rate after 3 months.

  2. Acute radiation-induced events

    Time frame: 18 months

    Acute radiation-induced events (within 3 months after treatment) according to CTCAE 4.0. Major concern will be on radiation myocarditis, pericarditis and pneumonitis/fibrosis. Needs of antiemetic drugs will be recorded.

  3. Late radiation-induced effects

    Time frame: 18 months

    Late radiation-induced effects (after 3 months after treatment) according to CTCAE 4.0. Major concern will be on radiation myocarditis, pericarditis and pneumonitis/fibrosis. Needs of antiemetic drugs will be recorded.

Secondary outcomes

  1. Time to death at any time

    Time frame: 18 months

  2. Time to arrhythmic storm

    Time frame: 90 days

    Time to arrhythmic storm (three or more documented episodes of VT within 24 hours) at any time and after 90-day treatment period.

  3. Time to appropriate ICD shock

    Time frame: 90 days

    Time to appropriate ICD shock at any time and after 90-day treatment period.

  4. Time to appropriate antitachycardial pacing by ICD

    Time frame: 90 days

    Time to appropriate antitachycardial pacing by ICD at any time and after 90-day treatment period.

  5. Hospitalization due to VT

    Time frame: 18 months

  6. Hospitalization due to chronic heart failure

    Time frame: 18 months

  7. Quality of life measured with EQ-5D questionnaire

    Time frame: 18 months

    Quality of life measurement using a standardised tool named EQ-5D. EQ-5D is a standardised instrument in the form of a questionnaire developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D instrument consists of a descriptive system and the EuroQol-visual analogue scales (EQ VAS). The quality of life is measured in 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The higher the score achieved, the higher the quality of life of the patient.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Hospital Nový Jičín
  • Hospital Podlesi
  • University of Ostrava

Registry information

Official study title

Phase I/II Study of 4-D Navigated Non-invasive Radiosurgical Ablation of Ventricular Tachycardia

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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