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RecruitingNCT05913375SMARTER-VTUpdated Oct 19, 2023

Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia

An interventional study of Stereotactic Body Radiotherapy in Ventricular Tachycardia, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Recruiting at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Ventricular Tachycardia

Keywords

  • radioablation
  • stereotactic arrhythmia radioablation (STAR)
  • stereotactic body radiotherapy (SBRT)
  • ventricular tachycardia
03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's planned enrollment of 20 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 63 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

Interventions

  • RadiationStereotactic Body Radiotherapy

    Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM)

    Also known as: Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

Secondary outcomes

  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

    Number of patients who developed VT with a different morphology than specified during qualification for the procedure

    Time frame: 12 months

  6. Early treatment safety

    Number of serious adverse events (SAE) in the first 3 months after the intervention

    Time frame: 3 months

  7. Long term treatment safety

    Number of SAE episodes within 12 months after the intervention

    Time frame: 12 months

  8. 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

    Time frame: 12 months

  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

    Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable)

    Time frame: 3 months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05913375
Lead 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
Responsible party
Sponsor
First posted
Jun 22, 2023
Start date
Jul 24, 2023
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Oct 19, 2023

Study contacts

Sławomir Blamek, MD, PhD, MBA
Contact
slawomir.blamek@io.gliwice.pl
+48322788052
Marcin Miszczyk, MD, PhD
Contact
marcin.miszczyk@io.gliwice.pl
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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