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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)

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

NCT ID

NCT05594368

First Posted

October 21, 2022

Last Updated

October 21, 2022

Sponsor

University of Zurich

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

Studies a U.S. FDA-regulated Device Product

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

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

nicolaus.andratschke@usz.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Mayinger, MD

Phone

0041 44 255 4238

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

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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