Ventricular TachycardiaSMART-VTNCT04642963
Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia
A study testing Cardiac Radiosurgery 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 safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT). 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?
- Cardiac Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesPoland
- Study dates
- 11 Sep 2020to 10 Jan 2023
- 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
- Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
- Clinically significant arrhythmia with at least 3 VT episodes per month despite adequate pharmacological treatment.
- At least one episode of monomorphic VT registered in electrophysiological examination.
- Recurrent VT despite at least one prior catheter ablation and adequate pharmacotherapy OR contraindications to catheter ablation and/or pharmacotherapy (i.e., patient with medically contraindicated catheter ablation is obliged to undergo only pharmacotherapy prior to study enrollment).
- Patient must be able to understand and be willing to sign a written informed consent document.
Who cannot join
- Heart failure requiring inotropic treatment or mechanical assistance
- Arrhythmia due to cardiac channelopathy
- Reversible source of arrhythmia
- NYHA (New York Heart Association) stage IV hearth failure
- Hearth infarction or cardiac surgery in last 3 months
- Life expectancy <6 months
Show all 10Show fewer
- Polymorphic VT
- Pregnancy
- Prior radiotherapy to the thoracic region (relative contraindication)
- Failure to induce VT during electrophysiological examination
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch
Gliwice, Silesian Voivodeship, 44-102
Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice
Katowice
About this study
Prospective single-arm study investigating the safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).
Read the detailed description
The standard of care for the treatment of Ventricular Tachycardia (VT) comprises of pharmacotherapy, ICD implantation and electrophysiology-guided catheter ablation. The treatment, however, is associated with a relatively high risk of VT recurrence. Given the limited therapeutic options and significant impact on patients quality of life, non-invasive cardiac radiosurgery has been recently gaining popularity in scientific literature as a viable alternative to salvage catheter ablations. Considering the scarcity of data from prospective trials and concern about the safety of the treatment method, this trial seeks to determine whether Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia (SMART-VT) meets the expected safety requirements for clinical use.
- Conditions
- Ventricular Tachycardia
- Being tested
- Cardiac Radiosurgery
- Keywords
- Ventricular Tachycardia, Ablation, Noninvasive, Stereotactic Body Radiation Therapy, Radiosurgery, Substrate Ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RadiosurgeryRadiation
Also called Stereotactic Arrhythmia Radioablation (STAR)
Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Radiosurgery | Experimental | Patients with ventricular tachycardia will undergo a non-invasive cardiac radiosurgery using one fraction of 25 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping. Receives: Radiation: Cardiac Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity evaluated using CTCAE v5.0 scale
The study aims to demonstrate the safety of the treatment method defined as 3-month observation without Grade III or higher adverse events in at least 6 out of 7 patients (1st stage), and in total in at least 9 out of 11 patients (2nd stage) with an interim safety analysis after obtaining data on primary outcome in first 7 patients.
Measured: 3 months
Secondary outcomes (6)
Efficacy of the treatment
Reduction of VT burden, ICD shocks and improvement in life quality as described by SF-36 (The Short Form Health Survey) v2 questionnaire. f eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 24 months
Biochemical markers of cardiac injury
Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) to assess the early cardiac muscle damage and changes in severity of congestive heart failure.
Measured: 24 months
Late toxicity and mortality
Assessment of late toxicity including occurrence of cardiac-related hospitalizations and death.
Measured: 24 months
Anti-arrhythmic drugs uptake
Changes in the anti-arrhythmic medications over time after treatment.
Measured: 24 months
Cardiac injury
Assessment of the post-treatment cardiac injury including left ventricular ejection fraction, echocardiography and morphological changes in imaging studies.
Measured: 24 months
Target volume delineation
Correlation of electrophysiological mapping with the results of additional cardiac imaging methods (MR, PET) - only in applicable patients (optional diagnostic methods)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start11 Sep 2020
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Slawomir Blamek, Maria Sklodowska-Curie National Research Institute of Oncology
- Investigators
- Sławomir Blamek, dr hab. n. med., Principal investigator, Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)Wojciech Wojakowski, prof. dr hab. n. med., Principal investigator, Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in KatowiceMarcin Miszczyk, dr n. med., Study chair, Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642963
- Sponsor's protocol ID
- SMART-VT
- Acronym
- SMART-VT
- Status last verified
- Mar 2023
- First submitted
- 19 Nov 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT04642963
- Acronym / sponsor ID
- SMART-VT / SMART-VT
- Conditions
- Ventricular Tachycardia
- Keywords
- Ventricular Tachycardia, Ablation, Noninvasive, Stereotactic Body Radiation Therapy, Radiosurgery, Substrate Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 24 Nov 2020 (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 safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).
Detailed description
The standard of care for the treatment of Ventricular Tachycardia (VT) comprises of pharmacotherapy, ICD implantation and electrophysiology-guided catheter ablation. The treatment, however, is associated with a relatively high risk of VT recurrence. Given the limited therapeutic options and significant impact on patients quality of life, non-invasive cardiac radiosurgery has been recently gaining popularity in scientific literature as a viable alternative to salvage catheter ablations. Considering the scarcity of data from prospective trials and concern about the safety of the treatment method, this trial seeks to determine whether Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia (SMART-VT) meets the expected safety requirements for clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Radiosurgery | Experimental | Radiation: Cardiac RadiosurgeryPatients with ventricular tachycardia will undergo a non-invasive cardiac radiosurgery using one fraction of 25 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 (5 listed)
- Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
- Clinically significant arrhythmia with at least 3 VT episodes per month despite adequate pharmacological treatment.
- At least one episode of monomorphic VT registered in electrophysiological examination.
- Recurrent VT despite at least one prior catheter ablation and adequate pharmacotherapy OR contraindications to catheter ablation and/or pharmacotherapy (i.e., patient with medically contraindicated catheter ablation is obliged to undergo only pharmacotherapy prior to study enrollment).
- Patient must be able to understand and be willing to sign a written informed consent document.
Key exclusion criteria (10 listed)
- Heart failure requiring inotropic treatment or mechanical assistance
- Arrhythmia due to cardiac channelopathy
- Reversible source of arrhythmia
- NYHA (New York Heart Association) stage IV hearth failure
- Hearth infarction or cardiac surgery in last 3 months
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 |
|---|---|---|
| Cardiac RadiosurgeryAlso: Stereotactic Arrhythmia Radioablation (STAR)Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate. | Radiation | Cardiac Radiosurgery |
Primary outcome
Acute toxicity evaluated using CTCAE v5.0 scale
Time frame: 3 months
The study aims to demonstrate the safety of the treatment method defined as 3-month observation without Grade III or higher adverse events in at least 6 out of 7 patients (1st stage), and in total in at least 9 out of 11 patients (2nd stage) with an interim safety analysis after obtaining data on primary outcome in first 7 patients.
6 secondary outcomes
Efficacy of the treatment
Time frame: 24 months
Biochemical markers of cardiac injury
Time frame: 24 months
Late toxicity and mortality
Time frame: 24 months
Anti-arrhythmic drugs uptake
Time frame: 24 months
Cardiac injury
Time frame: 24 months
Target volume delineation
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Yes
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.
Sławomir Blamek, dr hab. n. med. principal investigator
Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
Wojciech Wojakowski, prof. dr hab. n. med. principal investigator
Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice
Marcin Miszczyk, dr n. med. study chair
Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Radiosurgery 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 15 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity evaluated using CTCAE v5.0 scale (time frame: 3 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 15 Mar 2023.