Cardiac RadiothErapy for VEntricular Tachycardia (CREVET)

Objective: To explore in our center the feasibility and safety of a SBRT treatment method for VT.

Study population: Patients with ventricular tachycardia that are refractory to dose-escalated antiarrhythmic drugs and where catheter ablation has either already been performed or is deemed to be unsuccessful or associated with high risks.

Intervention: Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate defined by electrophysiological mapping.

Main study endpoints: The primary aim is to explore the feasibility and safety of a SBRT treatment method for refractory VT. Secondary endpoints include an assessment of the efficacy of the treatment, quality of life, late toxicity and overall survival.

Patients will have to fill in a quality-of-life questionnaire before and after the radiotherapy treatment. The risk associated with this trial is an increase in toxicity.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Radiation: Stereotactic radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Berkovic, MD, PhD; Phone Number: +32-16-34-51-15; Email: Patrick.berkovic@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Patrick Berkovic, MD, PhD
    • Principal Investigator: Patrick Berkovic, MD, PhD
    • Sub-Investigator: Bert Vandenberk, MD, PhD
    • Sub-Investigator: Joris Ector, MD, PhD
    • Sub-Investigator: Cédric Draulans, MD, PhD
    • Sub-Investigator: Kenneth Poels, MSc, PhD
    • Sub-Investigator: Robin De Roover, MSc, PhD
    • Sub-Investigator: Jan Bogaert, MD, PhD
    • Sub-Investigator: Steven Dymarkowski, MD, PhD
    • Sub-Investigator: Walter Coudyzer, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient ≥ 18 years
• Presence of a structural heart disease and an implantable cardioverter defibrillator (ICD)
• Documented sustained monomorphic VT that requires ICD intervention (e.g., shock or anti-tachycardia stimulation)
• The VT is inducible by ICD via non-invasive programmed stimulation (NIPS) or during electrophysiology measurement
• Patient must have failed or become intolerant to at least one antiarrhythmic medication
• Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure, or have VT thought to arise from a protected location
• Ability to give a written informed consent and willingness to return for follow-up

Exclusion Criteria:

• Pregnancy or breastfeeding
• Lack of evidence of a myocardial scar triggering the VT
• Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm
• Advanced symptomatic heart failure defined as NYHA Class IV heart failure
• Previous radiotherapy with cardiac involvement
• Life expectancy < 6 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians
• Any condition that is deemed a contraindication in the judgment of the investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stereotactic body radiotherapy; Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate	Radiation: Stereotactic radiotherapy; Single-session high dose stereotactic radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of SBRT	Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient	From date of inclusion up to 1 year
Safety of SBRT	Measurement of acute and late toxicity assessed using the CTCAE v5.0	From radiotherapy up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of SBRT	Changes in the use of antiarrhythmic medication, reduction in VT burden	From inclusion up to 1 year
Health related quality-of-life	Measurement of the quality of life using the SF-36 questionnaire	From inclusion up to 1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: s66934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No