The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia (SMARTER-VT)

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: NCT05913375
Recruitment Status : Recruiting
First Posted : June 22, 2023
Last Update Posted : October 19, 2023
Sponsor:
Collaborator:
Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
Information provided by (Responsible Party):
Maria Sklodowska-Curie National Research Institute of Oncology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Prospective single-arm study investigating the efficacy and safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT) with reduced dose of radiation (20 Gy). The efficacy and safety outcome measures will be compared with historical control - patients treated within the SMART-VT study (NCT04642963) with a single dose of 25 Gy to test the hypothesis that reduced dose of radiation is similarly effective in terms of reduction of VT burden.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Radiation: Stereotactic Body Radiotherapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
Actual Study Start Date : July 24, 2023
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cardiac radioablation
Patients with ventricular tachycardia will undergo cardiac radiosurgery with one fraction of 20 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping.
 Radiation: Stereotactic Body Radiotherapy
Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM)
Other Name: Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy of the treatment [ Time Frame: 6 months ]

    Number of patients with a reduction of the number of ventricular tachycardia (VT) episodes by at least 50% within 6 months after the irradiation compared to the number of VT episodes within 6 months before the intervention (based on registration from ICD/CRT-D), including:

    • the number of high-energy discharges
    • number of low-energy discharges for VT that was treated with stereotactic radiotherapy (STAR)


Secondary Outcome Measures :
  1. Six-month survival without VT episodes [ Time Frame: 6 months ]
  2. Number of patients with complete elimination of ICD discharges [ Time Frame: 12 months ]
  3. Number of patients with a 90% reduction in the number of ICD discharges [ Time Frame: 12 months ]
  4. Number of hospitalizations due to VT episodes [ Time Frame: 12 months ]
  5. Recurrences outside the irradiated area [ Time Frame: 12 months ]
    Number of patients who developed VT with a different morphology than specified during qualification for the procedure

  6. Early treatment safety [ Time Frame: 3 months ]
    Number of serious adverse events (SAE) in the first 3 months after the intervention

  7. Long term treatment safety [ Time Frame: 12 months ]
    Number of SAE episodes within 12 months after the intervention

  8. Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage. [ Time Frame: 12 months ]
    Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and

  9. Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up [ Time Frame: 12 months ]
  10. Change in the need for antiarrhythmic drugs [ Time Frame: 12 months ]
  11. Evaluation of changes in the left ventricular ejection fraction [ Time Frame: 12 months ]
  12. Evaluation of changes in the morphology of the heart in the ultrasound examination [ Time Frame: 12 months ]
  13. Assessment of compliance of the results of additional imaging with the results of EAM [ Time Frame: 3 months ]
    Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

  • Age ≥ 18 years
  • Patients with structural heart disease
  • Patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillation (CRT-D)
  • Clinically symptomatic ventricular arrhythmia despite adequate treatment, with episodes of ventricular tachycardia occurring at least 3 times per month
  • At least one episode of monomorphic ventricular tachycardia recorded during an electrophysiological examination
  • Recurrent VT despite at least one previous failed attempt at percutaneous ablation or disqualification from this treatment method (eg, patients after percutaneous closure of patent foramen ovale, ventricular septal defect).
  • Persistent recurrence of VT despite adequate pharmacotherapy.
  • Informed consent of the patient to participate in the study.

Exclusion Criteria:

  • Premature ventricular contractions
  • Cardiac damage requiring inotropic treatment
  • Implantation of left ventricular assist device (LVAD)
  • Ventricular arrhythmia in the course of channelopathy
  • Reversible cause of VT
  • New York Heart Association (NYHA) stage IV heart failure
  • Myocardial infarction or cardiac surgery in the last 3 months.
  • Life expectancy less than 6 months
  • Polymorphic ventricular tachycardia
  • Pregnancy or breastfeeding
  • Substrate location that prevents safe radiotherapy (eg due to location relative to critical organs, or dose given during previous radiotherapy treatments).
  • Evidence of an active systemic, pulmonary or pericardial inflammatory process that has required systemic treatment in the past 6 months (eg disease-modifying drugs, steroids, immunosuppressants). Patients treated for sarcoidosis who are currently in remission on chronic immunosuppressive drugs, without current signs of an acute inflammatory process, may be included in the study.
  • Active, uncontrolled malignancy and/or chemo/immunotherapy in the past month or planned within the month following radioablation.
  • Lack of the informed consent
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05913375


Contacts
Layout table for location contacts
Contact: Sławomir Blamek, MD, PhD, MBA +48322788052 slawomir.blamek@io.gliwice.pl
Contact: Marcin Miszczyk, MD, PhD marcin.miszczyk@io.gliwice.pl

Locations
Layout table for location information
Poland
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch Recruiting
Gliwice, Poland, 44-102
Contact: Sławomir Blamek, MD, PhD, MBA    +48322788052    slawomir.blamek@io.gliwice.pl   
Contact: Marcin Miszczyk, MD, PhD       marcin.miszczyk@io.gliwice.pl   
Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia Recruiting
Katowice, Poland, 40-635
Contact: Wojciech Wojakowski, MD, PhD       welwetek@poczta.onet.pl   
Contact: Tomasz Jadczyk, MD, PhD       tomasz.jadczyk@gmail.com   
Sponsors and Collaborators
Maria Sklodowska-Curie National Research Institute of Oncology
Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
Investigators
Layout table for investigator information
Principal Investigator: Sławomir Blamek, MD, PhD, MBA Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Principal Investigator: Wojciech Wojakwoski, MD, PhD Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice
Study Chair: Marcin Miszczyk, MD, PhD Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Maria Sklodowska-Curie National Research Institute of Oncology
ClinicalTrials.gov Identifier: NCT05913375    
Other Study ID Numbers: KB/430-77/23
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: October 19, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared within the European Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM). The intention to share the anonymized data with the consortium will be clearly explained, and a written consent will be obtained from each participant.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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 Maria Sklodowska-Curie National Research Institute of Oncology:
radioablation
stereotactic arrhythmia radioablation (STAR)
stereotactic body radiotherapy (SBRT)
ventricular tachycardia
Additional relevant MeSH terms:
Layout table for MeSH terms
Arrhythmias, Cardiac
Tachycardia
Tachycardia, Ventricular
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease