SBRT for Ventricular Arrhythmia

Medical University of Graz

Status

Enrolling

Conditions

Ventricular Arrythmia

Treatments

Radiation: Stereotactic Antiarrhythmic Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06411392

35-439 e 22/23

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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