| NCT ID | NCT06411392 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Graz |
| Condition | Ventricular Arrythmia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-03-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06411392 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Arrythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06411392 currently recruiting?
Yes, NCT06411392 is actively recruiting participants. Contact the research team at tanja.langsenlehner@medunigraz.at for enrollment information.
Where is the NCT06411392 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT06411392 clinical trial?
NCT06411392 is sponsored by Medical University of Graz. The trial plans to enroll 10 participants.