Ventricular TachycardiaSMARTER-VTNCT05913375
Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
A study testing Stereotactic Body Radiotherapy in people with Ventricular Tachycardia, run by Maria Sklodowska-Curie National Research Institute of Oncology at 2 sites in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesPoland
- Study dates
- 24 Jul 2023to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Marcin Miszczyk, MD, PhD contact
Poland2 sites, 2 recruiting
- Recruiting
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, 44-102
Sławomir Blamek, MD, PhD, MBA, +48322788052, slawomir.blamek@io.gliwice.pl
Marcin Miszczyk, MD, PhD, marcin.miszczyk@io.gliwice.pl
- Recruiting
Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia
Katowice, 40-635
Wojciech Wojakowski, MD, PhD, welwetek@poczta.onet.pl
Tomasz Jadczyk, MD, PhD, tomasz.jadczyk@gmail.com
About this study
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.
- Conditions
- Ventricular Tachycardia
- Being tested
- Stereotactic Body Radiotherapy
- Keywords
- radioablation, stereotactic arrhythmia radioablation (STAR), stereotactic body radiotherapy (SBRT), ventricular tachycardia
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiotherapyRadiation
Also called Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery
Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM)
| Study group | Role | What they receive |
|---|---|---|
| Cardiac radioablation | Experimental | 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. Receives: Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (13)
Six-month survival without VT episodes
Measured: 6 months
Number of patients with complete elimination of ICD discharges
Measured: 12 months
Number of patients with a 90% reduction in the number of ICD discharges
Measured: 12 months
Number of hospitalizations due to VT episodes
Measured: 12 months
Recurrences outside the irradiated area
Number of patients who developed VT with a different morphology than specified during qualification for the procedure
Measured: 12 months
Early treatment safety
Number of serious adverse events (SAE) in the first 3 months after the intervention
Measured: 3 months
Long term treatment safety
Number of SAE episodes within 12 months after the intervention
Measured: 12 months
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
Measured: 12 months
Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up
Measured: 12 months
Change in the need for antiarrhythmic drugs
Measured: 12 months
Evaluation of changes in the left ventricular ejection fraction
Measured: 12 months
Evaluation of changes in the morphology of the heart in the ultrasound examination
Measured: 12 months
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start24 Jul 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
- Responsible party
- Sponsor
- Investigators
- Sławomir Blamek, MD, PhD, MBA, Principal investigator, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice BranchWojciech Wojakwoski, MD, PhD, Principal investigator, Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in KatowiceMarcin Miszczyk, MD, PhD, Study chair, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913375
- Sponsor's protocol ID
- KB/430-77/23
- Acronym
- SMARTER-VT
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT05913375
- Acronym / sponsor ID
- SMARTER-VT / KB/430-77/23
- Conditions
- Ventricular Tachycardia
- Keywords
- radioablation, stereotactic arrhythmia radioablation (STAR), stereotactic body radiotherapy (SBRT), ventricular tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac radioablation | Experimental | Radiation: Stereotactic Body RadiotherapyPatients with ventricular tachycardia will undergo cardiac radiosurgery with one fraction of 20 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body RadiotherapyAlso: Stereotactic Arrhythmia Radioablation, Cardiac RadiosurgeryNon-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM) | Radiation | Cardiac radioablation |
Primary outcome
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)
13 secondary outcomes
Six-month survival without VT episodes
Time frame: 6 months
Number of patients with complete elimination of ICD discharges
Time frame: 12 months
Number of patients with a 90% reduction in the number of ICD discharges
Time frame: 12 months
Number of hospitalizations due to VT episodes
Time frame: 12 months
Recurrences outside the irradiated area
Time frame: 12 months
Early treatment safety
Time frame: 3 months
Long term treatment safety
Time frame: 12 months
Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage.
Time frame: 12 months
Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up
Time frame: 12 months
Change in the need for antiarrhythmic drugs
Time frame: 12 months
Evaluation of changes in the left ventricular ejection fraction
Time frame: 12 months
Evaluation of changes in the morphology of the heart in the ultrasound examination
Time frame: 12 months
Assessment of compliance of the results of additional imaging with the results of EAM
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Miszczyk, MD, PhD contact
Sławomir Blamek, MD, PhD, MBA principal investigator
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Wojciech Wojakwoski, MD, PhD principal investigator
Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice
Marcin Miszczyk, MD, PhD study chair
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiotherapy in people with Ventricular Tachycardia, run by Maria Sklodowska-Curie National Research Institute of Oncology at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sławomir Blamek, MD, PhD, MBA (+48322788052, slawomir.blamek@io.gliwice.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.