Back to resultsStereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia (SMARTER-VT)
Primary Purpose
Ventricular Tachycardia
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring radioablation, stereotactic arrhythmia radioablation (STAR), stereotactic body radiotherapy (SBRT), ventricular tachycardia
Eligibility 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
Sites / Locations
- Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice BranchRecruiting
- Professor Leszek Giec Upper Silesian Medical Center of the Medical University of SilesiaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiac radioablation
Arm Description
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.
Outcomes
Primary Outcome Measures
Efficacy of the treatment
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
Six-month survival without VT episodes
Number of patients with complete elimination of ICD discharges
Number of patients with a 90% reduction in the number of ICD discharges
Number of hospitalizations due to VT episodes
Recurrences outside the irradiated area
Number of patients who developed VT with a different morphology than specified during qualification for the procedure
Early treatment safety
Number of serious adverse events (SAE) in the first 3 months after the intervention
Long term treatment safety
Number of SAE episodes within 12 months after the intervention
Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage.
Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and
Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up
Change in the need for antiarrhythmic drugs
Evaluation of changes in the left ventricular ejection fraction
Evaluation of changes in the morphology of the heart in the ultrasound examination
Assessment of compliance of the results of additional imaging with the results of EAM
Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable)
Full Information
NCT ID
NCT05913375
First Posted
June 13, 2023
Last Updated
October 18, 2023
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
1. Study Identification
Unique Protocol Identification Number
NCT05913375
Brief Title
Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
Acronym
SMARTER-VT
Official Title
Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
radioablation, stereotactic arrhythmia radioablation (STAR), stereotactic body radiotherapy (SBRT), ventricular tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiac radioablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy
Other Intervention Name(s)
Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery
Intervention Description
Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM)
Primary Outcome Measure Information:
Title
Efficacy of the treatment
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Six-month survival without VT episodes
Time Frame
6 months
Title
Number of patients with complete elimination of ICD discharges
Time Frame
12 months
Title
Number of patients with a 90% reduction in the number of ICD discharges
Time Frame
12 months
Title
Number of hospitalizations due to VT episodes
Time Frame
12 months
Title
Recurrences outside the irradiated area
Description
Number of patients who developed VT with a different morphology than specified during qualification for the procedure
Time Frame
12 months
Title
Early treatment safety
Description
Number of serious adverse events (SAE) in the first 3 months after the intervention
Time Frame
3 months
Title
Long term treatment safety
Description
Number of SAE episodes within 12 months after the intervention
Time Frame
12 months
Title
Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage.
Description
Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and
Time Frame
12 months
Title
Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up
Time Frame
12 months
Title
Change in the need for antiarrhythmic drugs
Time Frame
12 months
Title
Evaluation of changes in the left ventricular ejection fraction
Time Frame
12 months
Title
Evaluation of changes in the morphology of the heart in the ultrasound examination
Time Frame
12 months
Title
Assessment of compliance of the results of additional imaging with the results of EAM
Description
Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sławomir Blamek, MD, PhD, MBA
Phone
+48322788052
Email
slawomir.blamek@io.gliwice.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Marcin Miszczyk, MD, PhD
Email
marcin.miszczyk@io.gliwice.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sławomir Blamek, MD, PhD, MBA
Organizational Affiliation
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wojciech Wojakwoski, MD, PhD
Organizational Affiliation
Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcin Miszczyk, MD, PhD
Organizational Affiliation
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sławomir Blamek, MD, PhD, MBA
Phone
+48322788052
Email
slawomir.blamek@io.gliwice.pl
First Name & Middle Initial & Last Name & Degree
Marcin Miszczyk, MD, PhD
Email
marcin.miszczyk@io.gliwice.pl
Facility Name
Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wojciech Wojakowski, MD, PhD
Email
welwetek@poczta.onet.pl
First Name & Middle Initial & Last Name & Degree
Tomasz Jadczyk, MD, PhD
Email
tomasz.jadczyk@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
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