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

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT05594368

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia	Device: Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The study is designed as a one arm, single-center dose escalation trial employing the i3+3 design.The study is designed as a one arm, single-center dose escalation trial employing the i3+3 design.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dose Escalation for Stereotactic Cardiac Radiation Therapy of Recurrent Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)	Device: Dose 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.

Arm

Intervention/Treatment

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

Device: Dose 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.

Outcome Measures

Primary Outcome Measures

safety measured by registered radiation associated adverse events up to 90 days [up to 90 days]
safety measured by registered radiation associated adverse events

Secondary Outcome Measures

Radiation associated serious adverse event (at least grade 4 or 5 according to CTCAE v5) [As assessed at 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zürich	Zurich	Switzerland	8091

Sponsors and Collaborators

University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT05594368

Other Study ID Numbers:

2022-00262

First Posted:

Oct 26, 2022

Last Update Posted:

Oct 26, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tachycardia

Tachycardia, Ventricular

Study Results

No Results Posted as of Oct 26, 2022