PROspective feasibility study of STereotactic Arrhythmia Radioablatio

Recruiting

• Conditions: ventricular arrhythmia; ventricular tachycardia; 10007521

• Registration Number: NL-OMON51078
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 11

Inclusion Criteria

medication and ablation therapy refractory ventricular arrhythmia

Exclusion Criteria

extreme arrhythmia substrate: polymorphic VT/VF, >3 distinct clinical VT
morphologies, >5 distinct induced VT morphologies during testing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acceptable acute toxicity defined by CTCAE v5.0. The incidence of serious<br /><br>adverse events (SAEs, defined as >= grade 3) should be <33,33% within 90 days of<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To demonstrate the efficacy of STAR as defined by the reduction in VT burden<br /><br>(number of ICD interventions and/or ATP, changes in antiarrhythmic medication),<br /><br>and improvement in quality of life (PROM questionnaires). The reduction in VT<br /><br>burden should be >= 50% after treatment compared to the 6 month period prior to<br /><br>STAR. To record (potential) late treatment related toxicity after STAR.</p><br>