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Non-invasive Ablation of Ventricular Tachycardia

Primary Purpose

Ventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
4-D navigated stereotactic radiosurgical ablation
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring scar-related, ventricular tachycardia, substrate ablation, stereotactic radiosurgery, functional radiosurgery, 4D navigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Nový Jičín, Nuclear Medicine - PET/CT
  • University Hospital Ostrava
  • Hospital Podlesí

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4-D navigated stereotactic radiosurgical ablation

Arm Description

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

Outcomes

Primary Outcome Measures

Composite of death
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.
Acute radiation-induced events
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.
Late radiation-induced effects
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 Outcome Measures

Time to death at any time
Time to arrhythmic storm
Time to arrhythmic storm (three or more documented episodes of VT within 24 hours) at any time and after 90-day treatment period.
Time to appropriate ICD shock
Time to appropriate ICD shock at any time and after 90-day treatment period.
Time to appropriate antitachycardial pacing by ICD
Time to appropriate antitachycardial pacing by ICD at any time and after 90-day treatment period.
Hospitalization due to VT
Hospitalization due to chronic heart failure
Quality of life measured with EQ-5D questionnaire
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.

Full Information

First Posted
May 18, 2018
Last Updated
December 5, 2022
Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava, Hospital Podlesi, Hospital Nový Jičín
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1. Study Identification

Unique Protocol Identification Number
NCT03601832
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava, Hospital Podlesi, Hospital Nový Jičín

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
scar-related, ventricular tachycardia, substrate ablation, stereotactic radiosurgery, functional radiosurgery, 4D navigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients enroled in the study are allocated to one group with 4-D navigated stereotactic radiosurgical ablation.
Masking
None (Open Label)
Masking Description
No masking in this study.
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4-D navigated stereotactic radiosurgical ablation
Arm Type
Experimental
Arm Description
The patients enroled to this arm of the study will undergo 4-D navigated stereotactic radiosurgical ablation.
Intervention Type
Procedure
Intervention Name(s)
4-D navigated stereotactic radiosurgical ablation
Intervention Description
4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia in patients with sustained monomorphic ventricular tachycardia/tachycardias after myocardial infarction.
Primary Outcome Measure Information:
Title
Composite of death
Description
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.
Time Frame
90 days
Title
Acute radiation-induced events
Description
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.
Time Frame
18 months
Title
Late radiation-induced effects
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Time to death at any time
Time Frame
18 months
Title
Time to arrhythmic storm
Description
Time to arrhythmic storm (three or more documented episodes of VT within 24 hours) at any time and after 90-day treatment period.
Time Frame
90 days
Title
Time to appropriate ICD shock
Description
Time to appropriate ICD shock at any time and after 90-day treatment period.
Time Frame
90 days
Title
Time to appropriate antitachycardial pacing by ICD
Description
Time to appropriate antitachycardial pacing by ICD at any time and after 90-day treatment period.
Time Frame
90 days
Title
Hospitalization due to VT
Time Frame
18 months
Title
Hospitalization due to chronic heart failure
Time Frame
18 months
Title
Quality of life measured with EQ-5D questionnaire
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakub Cvek, Ing.,MD,Ph.D.
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nový Jičín, Nuclear Medicine - PET/CT
City
Nový Jičín
State/Province
Moravian-Silesian Region
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Hospital Podlesí
City
Třinec
State/Province
Moravian-Silesian Region
ZIP/Postal Code
739 61
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Non-invasive Ablation of Ventricular Tachycardia

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