ClinicalTrials.gg
RecruitingNCT05594368DEFT STARUpdated Aug 21, 2026

Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial

A Phase 1 interventional study of Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT) in Ventricular Tachycardia, sponsored by University of Zurich. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by University of Zurich · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2022, registered Oct 2022).
  • Started Jul 2022; still recruiting 4 years 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Tachycardia, Ventricular with a site in Switzerland — 6 open to participants now, 7 under way, none of them phase 3. Tachycardia, Ventricular · Switzerland.

Planned enrollment
14th of 14
15 · median 151
Started
2022
with 1 other
Phase 1
Only one
of the 21
Registered
17th of 21
by date

Among the 21 studies in Tachycardia, Ventricular with a site in Switzerland, this one is the 14th largest by planned enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2022, is the only one in phase 1, and was the 17th registered.

Tachycardia, Ventricular

451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.

Browse Tachycardia, Ventricular studies →

Open to participants now

6 of the 21 studies in Tachycardia, Ventricular with a site in Switzerland are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 85 Tachycardia, Ventricular studies recruiting now, 66 (78%) set no upper age limit and 1 (1%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Ventricular Tachycardia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 must be provided

Exclusion criteria

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 .

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)

    Device: Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)

Interventions

  • DeviceDose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)

    Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT) refractory to conventional antiarrhythmic and catheter ablation-based therapy. First patients will be treated with a dose from 25 Gy prescribed to the 65-90% target volume encompassing isodose escalating to a maximum of 32.5 Gy prescribed to the 65-90% isodose.

06

What researchers measure

Primary outcomes

  1. safety measured by registered radiation associated adverse events up to 90 days

    safety measured by registered radiation associated adverse events

    Time frame: up to 90 days

Secondary outcomes

  1. Radiation associated serious adverse event (at least grade 4 or 5 according to CTCAE v5)

    Time frame: As assessed at 90 days

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • Kovacs B, Mayinger M, Ehrbar S, Fesslmeier D, Ahmadsei M, Sazgary L, Manka R, Alkadhi H, Ruschitzka F, Duru F, Papachristofilou A, Sticherling C, Blamek S, Golba KS, Guckenberger M, Saguner AM, Andratschke N. Dose escalation for stereotactic arrhythmia radioablation of recurrent ventricular tachyarrhythmia - a phase II clinical trial. Radiat Oncol. 2023 Nov 8;18(1):185. doi: 10.1186/s13014-023-02361-x. PubMed 37941012 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2022 (actual). Primary completion is estimated for Dec 2027, 65 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2022
First posted
Oct 26, 2022
StartActual
Jul 1, 2022
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05594368
Responsible party
Sponsor
First posted
Oct 26, 2022
Start date
Jul 1, 2022
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

Nicolaus Andratschke, MD
Contact
nicolaus.andratschke@usz.ch
0041 44 255 4238
Michael Mayinger, MD
Contact
michael.mayinger@usz.ch
0041 44 255 4238

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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