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

University of Zurich2 sites in 2 countries15 target enrollmentJuly 1, 2022

ConditionsVentricular Tachycardia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Ventricular Tachycardia
Sponsor: University of Zurich
Enrollment: 15
Locations: 2
Primary Endpoint: safety measured by registered radiation associated adverse events up to 90 days
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

December 31, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Zurich

Responsible Party

Sponsor

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.