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Trial record 3 of 134 for:    Recruiting, Not yet recruiting, Available Studies | Tachycardia

Stereotactic Non-invasive Ablation of Ventricular Tachycardia

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ClinicalTrials.gov Identifier: NCT03819504
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborators:
Institute for Clinical and Experimental Medicine Prague (Cardiac Centre)
Hospital Podlesi (Department of Cardiology)
Information provided by (Responsible Party):
University Hospital Ostrava

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

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Procedure: 4-D navigated stereotactic radio surgical ablation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Cardiovascular hospitalisations [ Time Frame: 53 months ]
    The hospitalisations due to cardiovascular indications will be observed.

  4. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819504


Contacts
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Contact: Kateřina Vítková, RNDr.,Ph.D. 0042059737 ext 2544 katerina.vitkova@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz

Locations
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Czechia
Institute for Clinical and Experimental Medicine Prague Recruiting
Prague, Central Bohemia, Czechia, 14021
Contact: Josef Kautzner, prof.,MD,CSc    0042023605 ext 5006    josef.kautzner@ikem.cz   
Principal Investigator: Josef Kautzner, prof.,MD,CSc.         
University Hospital Ostrava Recruiting
Ostrava-Poruba, Czech Republic, Czechia, 708 52
Contact: Kateřina Vítková, RNDr.,PhD    0042059737 ext 2544    katerina.vitkova@fno.cz   
Contact: Jiří Hynčica    0042059737 ext 25á7    jiri.hyncica@fno.cz   
Principal Investigator: Jakkub Cvek, Ass.Prof.,MD,Ing.,PhD         
Hospital Podlesí Recruiting
Třinec, Moravian-Silesian Region, Czechia, 73961
Contact: Radek Neuwirth, MD    0042055830 ext 4140    radek.neuwirth@npo.agel.cz   
Principal Investigator: Radek Neuwirth, MD         
Sponsors and Collaborators
University Hospital Ostrava
Institute for Clinical and Experimental Medicine Prague (Cardiac Centre)
Hospital Podlesi (Department of Cardiology)
Investigators
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Study Chair: Jakub Cvek, Ass.Prof.,MD,Ing.,PhD University Hospital Ostrava

Publications:

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03819504     History of Changes
Other Study ID Numbers: STAR-VT
NV19-02-00212 ( Other Grant/Funding Number: Ministry of Health of the Czech Republic )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators have not decided to share the individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Ostrava:
Structural Heart Disease
Ventricular Tachycardia
Substrate Ablation
Stereotactic Radiosurgery
Functional Radiosurgery
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Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes