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Stereotactic Non-invasive Ablation of Ventricular Tachycardia

Primary Purpose

Ventricular Tachycardia

Status
Withdrawn
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
4-D navigated stereotactic radio surgical 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 Structural Heart Disease, Ventricular Tachycardia, Substrate Ablation, Stereotactic Radiosurgery, Functional Radiosurgery, 4D navigation

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Clinical and Experimental Medicine Prague
  • University Hospital Ostrava
  • Hospital Podlesí

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4-D navigated stereotactic radiosurgical ablation

Arm Description

Patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias will undergo 4-D navigated stereotactic radiosurgical ablation

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
Cardiovascular hospitalisations
The hospitalisations due to cardiovascular indications will be observed.
Change in quality of life
Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. 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 quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life.

Full Information

First Posted
January 21, 2019
Last Updated
October 15, 2020
Sponsor
University Hospital Ostrava
Collaborators
Institute for Clinical and Experimental Medicine, Hospital Podlesi
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1. Study Identification

Unique Protocol Identification Number
NCT03819504
Brief Title
Stereotactic Non-invasive Ablation of Ventricular Tachycardia
Official Title
STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Change in the design of the study
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
Institute for Clinical and Experimental Medicine, Hospital Podlesi

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
STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Structural Heart Disease, 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
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4-D navigated stereotactic radiosurgical ablation
Arm Type
Experimental
Arm Description
Patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias will undergo 4-D navigated stereotactic radiosurgical ablation
Intervention Type
Procedure
Intervention Name(s)
4-D navigated stereotactic radio surgical ablation
Intervention Description
4-D navigated stereotactic radio surgical ablation will be performed in patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias
Primary Outcome Measure Information:
Title
Change of sustained VT burden in three 3-month intervals
Description
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
Title
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
Description
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
Title
3. Rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0.
Description
The rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0 will be observed.
Time Frame
53 months
Secondary Outcome Measure Information:
Title
Composite endpoint of all-cause death and appropriate ICD shock
Description
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
Title
Electric storm recurrence
Description
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
Title
Cardiovascular hospitalisations
Description
The hospitalisations due to cardiovascular indications will be observed.
Time Frame
53 months
Title
Change in quality of life
Description
Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. 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 quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life.
Time Frame
53 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakub Cvek, Ass.Prof.,MD,Ing.,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Study Chair
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine Prague
City
Prague
State/Province
Central Bohemia
ZIP/Postal Code
14021
Country
Czechia
Facility Name
University Hospital Ostrava
City
Ostrava-Poruba
State/Province
Czech Republic
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Hospital Podlesí
City
Třinec
State/Province
Moravian-Silesian Region
ZIP/Postal Code
73961
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators have not decided to share the individual participant data with other researchers.
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Stereotactic Non-invasive Ablation of Ventricular Tachycardia

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