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Recruiting NCT06744530

Cardiac RadiothErapy for VEntricular Tachycardia II

— Observational Ventricular Tachycardia (VT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stereotactic radiotherapy ablation.
Who it may be relevant to
Registry conditions: Ventricular Tachycardia (VT). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cardiac RadiothErapy for VEntricular Tachycardia II - a Prospective Observational Cohort Study

Overview

Steoreotactic therapy radioablation has become a standard of care option for patients with therapy-refractory ventricular tachycardia, yet long-term outcome is lacking. The objective of this study is to evaluate the long-term outcomes, both efficacy and safety, after STAR in patients with therapy-refractory ventricular tachycardia.

Interventions

  • Procedure stereotactic radiotherapy ablation
    Single dose of 25 Gy up to 32.5 Gy on the myocardium in patients with therapy-refractory ventricular tachycardia

Primary outcome measures

  • Change in VT burden [Time frame: 48 months]
Secondary outcome measures (6)
  • Quality of Life [Time frame: Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months]
  • All-cause mortality [Time frame: 48 months]
  • Radiotherapy toxicity [Time frame: 48 months]
  • Left ventricular function [Time frame: Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months]
  • Evolution of valve disease [Time frame: Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months]
  • Change of coronary artery disease [Time frame: Baseline, 2 years and 4 years]

Eligibility criteria

Inclusion criteria

  • Eligible for STAR for therapy-refractory VT based on a multidisciplinary discussion
  • Ability to give a written informed consent and willingness to return for follow-up

Exclusion criteria

  • Contra-indications for STAR, including pregnancy or breastfeeding, previous radiotherapy with cardiac involvement, life-expectancy < 6 months in the absence of VT
  • Any condition that is deemed a contraindication in the judgment of the investigators

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Identifiers

NCT: NCT06744530 · S69812

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗