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

NCT05594368 | Recruiting Phase 1 DMC

• 1 other identifier: 2022-00262
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

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.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

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

  safety measured by registered radiation associated adverse events

  up to 90 days

Secondary Outcomes (1)

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

  As assessed at 90 days

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

University Hospital Ostrava

Ostrava, Czechia

RECRUITING

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 37941012 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolaus Andratschke, MD

CONTACT

0041 44 255 4238; nicolaus.andratschke@usz.ch

Michael Mayinger, MD

CONTACT

0041 44 255 4238; michael.mayinger@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

CH (1); CZ (1)