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

Primary Purpose

Ventricular Tachycardia

Status
Recruiting
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

safety measured by registered radiation associated adverse events 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)

Full Information

First Posted
October 21, 2022
Last Updated
October 21, 2022
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05594368
Brief Title
Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial
Acronym
DEFT STAR
Official Title
Dose Escalation for Stereotactic Cardiac Radiation Therapy of Recurrent Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
The study is designed as a one arm, single-center dose escalation trial employing the i3+3 design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
safety measured by registered radiation associated adverse events up to 90 days
Description
safety measured by registered radiation associated adverse events
Time Frame
up to 90 days
Secondary Outcome Measure Information:
Title
Radiation associated serious adverse event (at least grade 4 or 5 according to CTCAE v5)
Time Frame
As assessed at 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolaus Andratschke, MD
Phone
0041 44 255 4238
Email
nicolaus.andratschke@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Mayinger, MD
Phone
0041 44 255 4238
Email
michael.mayinger@usz.ch
Facility Information:
Facility Name
University Hospital Zurich
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Mayinger, MD
Phone
0041432530691
Email
michael.mayinger@usz.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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