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Recruiting

NCT Number: NCT06411392

SBRT for Ventricular Arrhythmia

The aim of this study is to demonstrate the safety and efficacy of STAR (Stereotactic Antiarrhythmic Radiotherapy) in patients with VT (ventricular tachycardia) who are unresponsive to standard treatments. Additionally, the planned study aims to provide further insights into the effects of STAR on VT burden, ICD interventions, and insights regarding late toxicities, particularly those related to the heart, which are currently not well understood.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, 8036, Austria

Location status: Recruiting

Location contact

Daniel Scherr, MD

PRINCIPAL_INVESTIGATOR

Lukas Seiß

SUB_INVESTIGATOR

Martin Manninger-Wünscher, MD

SUB_INVESTIGATOR

Peter Winkler, PhD

SUB_INVESTIGATOR

Tanja Langsenlehner, MD

CONTACT

[email protected]

004331638587869

Tanja Langsenlehner, MD

PRINCIPAL_INVESTIGATOR

Thomas Brunner, MD

SUB_INVESTIGATOR

Ursula Rohrer, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Recurrent VTs/VES with significant burden despite guideline-directed therapy
  • Existing protective ICD (Implantable cardioverter-defibrillator) implantation except in the presence of contraindications
  • AND lack of response or intolerance to antiarrhythmic medication
  • AND status post ≥1 catheter ablation due to monomorphic VT(s) and VT early recurrence (<12 months after the last catheter ablation) OR contraindication for endocardial ablation (mechanical valve prosthesis, LV (left ventricular) thrombus, or lack of vascular access in suspicion of endocardial substrate)
  • MINIMAL VT BURDEN: The patient must have had at least 3 VT episodes (sustained VT, ICD-ATP, or ICD shock) in the last 3 months prior to study enrollment.
  • Presence of suitability for radiation therapy with respect to SBRT
  • Age ≥ 18 years
  • Existing informed consent

Exclusion criteria

  • Acute myocardial infarction or percutaneous coronary intervention or heart surgery (<3 months before study enrollment)
  • Status post intra-thoracic pre-radiation
  • Immediate proximity to radiosensitive structures (e.g., esophagus) making therapy unsafe to administer
  • Advanced symptomatic heart failure (NYHA Class IV)
  • Polymorphic VT or ventricular fibrillation (confirmed in 12-lead ECG and/or ICD interrogation)
  • Extensive myocardial scar substrate that would result in too large of a radiation volume
  • Life expectancy < 6 months considering all comorbidities and in the Seattle Heart Failure Model
  • Presence of a Left Ventricular Assist Device (LVAD)
  • Use of cytotoxic medications
  • Pregnancy or lactation - negative pregnancy test within 14 days before study entry required for women of childbearing potential

Treatment and study plan

Stereotactic Antiarrhythmic Radiotherapy

Radiation

Patients with ventricular tachycardia will undergo cardiac stereotactic antiarrhythmic radiotherapy with a single fraction of 25 Gy to the arrhythmia substrate, as determined by electrophysiological cardiac mapping.

Primary outcomes

  1. Safety of treatment

    Time frame: 30 days

    Demonstration of acute (≤ 30 days) safety of non-invasive stereotactic antiarrhythmic radiotherapy for ventricular arrhythmia (STAR). The primary safety endpoint is defined as ≤ 20% rate of severe adverse events according to CTCAE v5.0 criteria

  2. Efficacy of treatment

    Time frame: 6 months

    The efficacy endpoint is defined by the number of patients experiencing a reduction in ventricular tachycardia episodes, compared to the six-month period prior to SBRT treatment and the six-month period post- SBRT.

Secondary outcomes

  1. Evaluation of changes in the left ventricular ejection fraction

    Time frame: 12 months

    Evaluation of changes in the left ventricular ejection fraction analyzed with echocardiography

  2. Evaluation of mortality

    Time frame: 12 months

    Analysis of cardiac mortality during post-treatment follow-up

  3. Assessment of late side effects

    Time frame: 12 months

    Assessment of radiation-induced cardiac late side effects using late iodine computed tomography

Study contacts

Contact information is provided by the study sponsor or research team.

Tanja Langsenlehner, MD

CONTACT

[email protected]

004331638587869

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Stereotactic Antiarrhythmic Radiotherapy for Ventricular Arrhythmia in Austria (Austrian STAR)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 13, 2024
Registry last updated
May 13, 2024

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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