CREVET: Cardiac RadiothErapy for VEntricular Tachycardia

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT05973578

Collaborator

(none)

Enrollment

Location

Arm

35.3

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia	Radiation: Stereotactic radiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cardiac RadiothErapy for VEntricular Tachycardia

Actual Study Start Date :

May 23, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen KU Leuven

ClinicalTrials.gov Identifier:

NCT05973578

Other Study ID Numbers:

s66934

First Posted:

Aug 3, 2023

Last Update Posted:

Aug 3, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tachycardia

Tachycardia, Ventricular

Study Results

No Results Posted as of Aug 3, 2023