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NCT Number: NCT04642963

Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

Prospective single-arm study investigating the safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch, Gliwice, Silesian Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Polymorphic VT
  • Pregnancy
  • Prior radiotherapy to the thoracic region (relative contraindication)
  • Failure to induce VT during electrophysiological examination

Treatment and study plan

Cardiac Radiosurgery

Radiation

Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.

Other names: Stereotactic Arrhythmia Radioablation (STAR)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Efficacy of the treatment

    Time frame: 24 months

    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.

  2. Biochemical markers of cardiac injury

    Time frame: 24 months

    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.

  3. Late toxicity and mortality

    Time frame: 24 months

    Assessment of late toxicity including occurrence of cardiac-related hospitalizations and death.

  4. Anti-arrhythmic drugs uptake

    Time frame: 24 months

    Changes in the anti-arrhythmic medications over time after treatment.

  5. Cardiac injury

    Time frame: 24 months

    Assessment of the post-treatment cardiac injury including left ventricular ejection fraction, echocardiography and morphological changes in imaging studies.

  6. Target volume delineation

    Time frame: 24 months

    Correlation of electrophysiological mapping with the results of additional cardiac imaging methods (MR, PET) - only in applicable patients (optional diagnostic methods)

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Registry information

Acronym: SMART-VT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2020
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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