Stereotactic Non-invasive Ablation of Ventricular Tachycardia

October 15, 2020 updated by: University Hospital Ostrava

STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Central Bohemia
      • Prague, Central Bohemia, Czechia, 14021
        • Institute for Clinical and Experimental Medicine Prague
    • Czech Republic
      • Ostrava-Poruba, Czech Republic, Czechia, 708 52
        • University Hospital Ostrava
    • Moravian-Silesian Region
      • Třinec, Moravian-Silesian Region, Czechia, 73961
        • Hospital Podlesí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4-D navigated stereotactic radiosurgical ablation
Patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias will undergo 4-D navigated stereotactic radiosurgical ablation
Procedure: 4-D navigated stereotactic radio surgical ablation
4-D navigated stereotactic radio surgical ablation will be performed in patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of sustained VT burden in three 3-month intervals
Time Frame: 50 months
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.
50 months
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
Time Frame: 50 months
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.
50 months
3. Rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0.
Time Frame: 53 months
The rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0 will be observed.
53 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of all-cause death and appropriate ICD shock
Time Frame: 50 months
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.
50 months
Electric storm recurrence
Time Frame: 53 months
The recurrence of electric storm will be observed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
53 months
Cardiovascular hospitalisations
Time Frame: 53 months
The hospitalisations due to cardiovascular indications will be observed.
53 months
Change in quality of life
Time Frame: 53 months
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.
53 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

Institute for Clinical and Experimental Medicine
Hospital Podlesi

Investigators

  • Study Chair: Jakub Cvek, Ass.Prof.,MD,Ing.,PhD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR-VT
  • NV19-02-00212 (Other Grant/Funding Number: Ministry of Health of the Czech Republic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The investigators have not decided to share the individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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