NCT05594368 Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial
| NCT ID | NCT05594368 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Zurich |
| Condition | Ventricular Tachycardia |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2027-12-31 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2022-07-01 with a primary completion date of 2027-12-31.
⚠ 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 objective of this study is to demonstrate that higher radiation doses are necessary to induce transmural scar formation which is currently assumed to be the underlying mechanism of successful long-term efficacy of VT treatment and therefore dose-escalation will lead to a significantly reduced long-term VT recurrence rate compared to the currently applied single dose of 25 Gy.
Eligibility Criteria
Inclusion Criteria: Patients with structural heart disease, in particular ischemic and non-ischemic cardiomyopathy: Implanted ICD and/or CRT-D. Prior ≥1 failed catheter ablation (with endocardial ± epicardial approach based on the substrate location and the ECG morphology of clinical VTs) procedure to control sustained monomorphic VT using currently recommended mapping and ablation techniques,2 or patients in whom ablation is not feasible. Reasons for lack of epicardial ablation and non-feasibility of catheter ablation must be specified. Sustained VT recurrence after catheter ablation on optimised antiarrhythmic medication. Age ≥18 years. IRB-approved, written informed consent must be provided Exclusion Criteria: Patients with only premature ventricular contractions. Patients with sustained VT/VF who demonstrate: Acute myocardial infarction; Primary electrical disease (channelopathy); Reversible and treatable cause (e.g., drug-induced or intoxication) of VT that can be adequately addressed otherwise; A target that cannot be safely and precisely defined based on stereotactic radiotherapy accuracy requirements (e.g., anatomical interference from OARs, overlapping prior radiation therapy to the thoracic region); Pregnancy or breastfeeding; Inability to provide informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05594368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Tachycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05594368 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05594368 currently recruiting?
Yes, NCT05594368 is actively recruiting participants. Contact the research team at nicolaus.andratschke@usz.ch for enrollment information.
Where is the NCT05594368 trial being conducted?
This trial is being conducted at Ostrava, Czechia, Zurich, Switzerland.
Who is sponsoring the NCT05594368 clinical trial?
NCT05594368 is sponsored by University of Zurich. The trial plans to enroll 15 participants.