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PROspective feasibility study of STereotactic Arrhythmia Radioablation

PROspective feasibility study of STereotactic Arrhythmia Radioablation - PRO-STAR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51078
Enrollment
11
Registered
2021-05-03
Start date
2021-11-22
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ventricular arrhythmia ventricular tachycardia

Interventions

A single fraction of 25 Gy will be given to the VT substrate. The VT substrate will be defined on an individual patient basis by a clinical cardiac electrophysiologist by combining different (imagin

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: medication and ablation therapy refractory ventricular arrhythmia

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Acceptable acute toxicity defined by CTCAE v5.0. The incidence of serious adverse events (SAEs, defined as >= grade 3) should be

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026