Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 136 for:    Recruiting, Not yet recruiting, Available Studies | Tachycardia

Non-invasive Ablation of Ventricular Tachycardia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03601832
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Faculty of medicine, University of Ostrava
Hospital Podlesí
Hospital Nový Jičín
Information provided by (Responsible Party):
University Hospital Ostrava

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

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Procedure: 4-D navigated stereotactic radiosurgical ablation Phase 1 Phase 2

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: Phase I/II Study of 4-D Navigated Non-invasive Radiosurgical Ablation of Ventricular Tachycardia
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4-D navigated stereotactic radiosurgical ablation
The patients enroled to this arm of the study will undergo 4-D navigated stereotactic radiosurgical ablation.
Procedure: 4-D navigated stereotactic radiosurgical ablation
4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia in patients with sustained monomorphic ventricular tachycardia/tachycardias after myocardial infarction.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03601832


Contacts
Layout table for location contacts
Contact: Petr Vávra, Ass.Prof.,MD,Ph.D. 0042059737 ext 2544 petr.vavra@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz

Locations
Layout table for location information
Czechia
Hospital Nový Jičín, Nuclear Medicine - PET/CT Recruiting
Nový Jičín, Moravian-Silesian Region, Czechia, 741 01
Principal Investigator: Andrea Bronczková, MD,MBA         
University Hospital Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 708 52
Contact: Petr Vávra, Ass.Prof.,MD,Ph.D.    0042059737 ext 2544    petr.vavra@fno.cz   
Contact: Jiří Hynčica    0042059737 ext 2587    jiri.hyncica@fno.cz   
Principal Investigator: Jakub Cvek, Ing.,MD,Ph.D.         
Hospital Podlesí Recruiting
Třinec, Moravian-Silesian Region, Czechia, 739 61
Contact: Radek Neuwirth, MD,MBA    00420558304 ext 140    radek.neuwirth@npo.agel.cz   
Sub-Investigator: Radek Neuwirth, MD,MBA         
Sub-Investigator: Otakar Jiravský, MD         
Sponsors and Collaborators
University Hospital Ostrava
Faculty of medicine, University of Ostrava
Hospital Podlesí
Hospital Nový Jičín
Investigators
Layout table for investigator information
Principal Investigator: Jakub Cvek, Ing.,MD,Ph.D. University Hospital Ostrava

Publications:

Layout table for additonal information
Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03601832     History of Changes
Other Study ID Numbers: NIRA-VT
18/RVO-FNOs/2018 ( Other Grant/Funding Number: University Hospital Ostrava )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Ostrava:
scar-related
ventricular tachycardia
substrate ablation
stereotactic radiosurgery
functional radiosurgery
4D navigation
Additional relevant MeSH terms:
Layout table for MeSH terms
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes