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Recruiting NCT06411392

SBRT for Ventricular Arrhythmia

No phase Interventional Ventricular Arrythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic Antiarrhythmic Radiotherapy.
Who it may be relevant to
Registry conditions: Ventricular Arrythmia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation Stereotactic Antiarrhythmic Radiotherapy
    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 outcome measures

  • Safety of treatment [Time frame: 30 days]
  • Efficacy of treatment [Time frame: 6 months]
Secondary outcome measures (3)
  • Evaluation of changes in the left ventricular ejection fraction [Time frame: 12 months]
  • Evaluation of mortality [Time frame: 12 months]
  • Assessment of late side effects [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Medical University of Graz — Graz

Publications

  • Volpato G, Compagnucci P, Cipolletta L, Parisi Q, Valeri Y, Carboni L, Giovagnoni A, Dello Russo A, Casella M. Safety and Efficacy of Stereotactic Arrhythmia Radioablation for the Treatment of Ventricular Tachycardia: A Systematic Review. Front Cardiovasc Med. 2022 Aug 22;9:870001. doi: 10.3389/fcvm.2022.870001. eCollection 2022. PMID 36072869
  • Belzile-Dugas E, Eisenberg MJ. Radiation-Induced Cardiovascular Disease: Review of an Underrecognized Pathology. J Am Heart Assoc. 2021 Sep 21;10(18):e021686. doi: 10.1161/JAHA.121.021686. Epub 2021 Sep 6. PMID 34482706
  • Robinson CG, Samson PP, Moore KMS, Hugo GD, Knutson N, Mutic S, Goddu SM, Lang A, Cooper DH, Faddis M, Noheria A, Smith TW, Woodard PK, Gropler RJ, Hallahan DE, Rudy Y, Cuculich PS. Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Circulation. 2019 Jan 15;139(3):313-321. doi: 10.1161/CIRCULATIONAHA.118.038261. PMID 30586734
  • Loo BW Jr, Soltys SG, Wang L, Lo A, Fahimian BP, Iagaru A, Norton L, Shan X, Gardner E, Fogarty T, Maguire P, Al-Ahmad A, Zei P. Stereotactic ablative radiotherapy for the treatment of refractory cardiac ventricular arrhythmia. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):748-50. doi: 10.1161/CIRCEP.115.002765. No abstract available. PMID 26082532
  • Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. 2017 Dec 14;377(24):2325-2336. doi: 10.1056/NEJMoa1613773. PMID 29236642

Identifiers

NCT: NCT06411392 · 35-439 e 22/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗