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Stereotactic Antiarrhythmic Radiotherapy for Ventricular Arrhythmia in Austria (Austrian STAR)

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
Contact Information
Primary
Tanja Langsenlehner, MD
tanja.langsenlehner@medunigraz.at
004331638587869
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2027-02
Participants
Target number of participants: 10
Treatments
Experimental: Stereotactic Antiarrhythmic Radiotherapy
Stereotactic antiarrhythmic radiotherapy for refractory ventricular arrhythmia
Related Therapeutic Areas
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov