Health TrialsbyHealthPanel

SBRT for Ventricular Arrhythmia

ConditionVentricular Arrythmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Graz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Stereotactic Antiarrhythmic RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of treatment

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

Time frame
30 days
2

Efficacy of treatment

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.

Time frame
6 months

Secondary outcomes

1

Evaluation of changes in the left ventricular ejection fraction

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

Time frame
12 months
2

Evaluation of mortality

Analysis of cardiac mortality during post-treatment follow-up

Time frame
12 months
3

Assessment of late side effects

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Graz

Lead sponsor

Source ClinicalTrials.gov
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