SBRT for Ventricular Arrhythmia

Not Applicable

Recruiting

• Conditions: Ventricular Arrythmia

• Registration Number: NCT06411392
• Lead Sponsor: Medical University of Graz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of treatment	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
Efficacy of treatment	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 Outcome Measures

Name	Time	Method
Evaluation of changes in the left ventricular ejection fraction	12 months	Evaluation of changes in the left ventricular ejection fraction analyzed with echocardiography
Evaluation of mortality	12 months	Analysis of cardiac mortality during post-treatment follow-up
Assessment of late side effects	12 months	Assessment of radiation-induced cardiac late side effects using late iodine computed tomography

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria